Food and Drug Administration (FDA) has approved a 505(b)(2) New Drug Application (NDA) for Atzumi™(dihydroergotamine (DHE)) nasal powder for the acute treatment of migraine with or without aura in adults Migraine is a neurological disorder that is thought to be the result of temporary changes in the chemicals with symptoms that are often incapacitating According to the American Migraine Foundation approximately 40 million Americans live with migraine It is the second leading cause of disability worldwide in terms of time lost to disability and most common cause of disability among young women "The approval of Atzumi is a milestone to celebrate providing a new option for the acute treatment of migraine combining long-proven benefits of DHE with a patient-friendly and easy-to-use delivery system developed based on SNBL's novel intranasal drug delivery platform technology," said Dr "We believe that Atzumi will contribute to improving the quality of life of patients struggling for relief from these highly disabling problems." "DHE plays a unique clinical role in the acute treatment of migraine providing patients long lasting effects and the unique ability to provide benefit even when taken late in a migraine attack will offer patients ease of use combined with the important known DHE clinical advantages" M.D., Vice President of the New England Institute for Neurology and Headache in Stamford Atzumi is a proprietary drug device product incorporating both Satsuma's advanced nasal powder formulation of dihydroergotamine (DHE) administered via its unique nasal delivery device The product is designed to provide patients an easy-to-use and easy-to-carry treatment option The FDA approval for Atzumi is based on two clinical studies (Phase 1 PK trial and ASCEND Phase 3 open-label rapid achievement of high DHE plasma concentrations and sustained DHE plasma levels over time as well as safety and tolerability in subjects with migraine DHE has long been recommended in published migraine treatment guidelines as a first-line acute treatment option for migraine and has significant advantages versus other anti-migraine treatments for many patients disadvantages of current DHE liquid nasal spray and injectable products including invasive and burdensome administration and/or sub-optimal clinical performance WARNING: PERIPHERAL ISCHEMIA FOLLOWING COADMINISTRATION WITH STRONG CYP3A4 INHIBITORS Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine with strong CYP3A4 inhibitors Because CYP3A4 inhibition elevates the serum levels of dihydroergotamine the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased concomitant use of Atzumi with strong CYP3A4 inhibitors is contraindicated Atzumi is an ergotamine derivative indicated for the acute treatment of migraine with or without aura in adults Atzumi is not indicated for the preventive treatment of migraine or for the management of hemiplegic migraine or migraine with brainstem aura Atzumi is not recommended in patients with: Most common adverse reactions (incidence >1%) were rhinitis Please see the Atzumi Full Prescribing Information including Boxed Warning and Medication Guide The risk information provided here is not comprehensive. The FDA-approved product labeling can be found at www.satsumarx.com You can also call 1-888-273-2480 for additional information Cautionary Note on Forward-Looking Statements SNBL does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make except as required by law or related stock exchange rule Past performance is not an indicator of future results and the results or statements of SNBL in this press release may not be indicative of guarantee or projection of SNBL's future results This press release contains information about product candidates that may not be available in all countries or may be available under different trademarks Nothing contained herein should be considered a solicitation promotion or advertisement for any prescription drugs including the ones under development Inquiries: Satsuma Pharmaceuticals, Inc.E-mail: [email protected]Website: www.satsumarx.com Health Care & Hospitals Medical Pharmaceuticals Pharmaceuticals Biotechnology Do not sell or share my personal information: By: Rachel Klemovitch Satsuma Pharmaceuticals, Inc. and its corporate parent, Shin Nippon Biomedical Laboratories, Ltd, announced that the U.S Food and Drug Administration (FDA) has approved a 505(b)(2) New Drug Application (NDA) for Atzumi (dihydroergotamine (DHE)) nasal powder for the acute treatment of migraine with or without aura in adults “The approval of Atzumi is a milestone to celebrate providing a new option for the acute treatment of migraine combining long-proven benefits of DHE with a patient-friendly and easy-to-use delivery system developed based on SNBL’s novel intranasal drug delivery platform technology,” said Dr “We believe that Atzumi will contribute to improving the quality of life of patients struggling for relief from these highly disabling problems.” Atzumi is the first and only product utilizing the SMART (Simple MucoAdhesive Release Technology) platform which combines a proprietary advanced powder and device technology to simplify the delivery of DHE Atzumi administration provided rapid and sustained DHE concentrations with low variability “DHE plays a unique clinical role in the acute treatment of migraine providing patients long lasting effects and the unique ability to provide benefit even when taken late in a migraine attack will offer patients ease of use combined with the important known DHE clinical advantages” Vice President of the New England Institute for Neurology and Headache in Stamford Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced except with the prior written permission of Rodman Media Newsletters and Deep Dive digital magazine More than a year after it was rejected by the FDA Satsuma Pharma's intranasal migraine therapy Atzumi (formerly STS101) has been given the go-ahead by the agency The drug – a new dry powder intranasal formulation of the well-established migraine therapy dihydroergotamine mesylate (DHE) – was submitted for approval in the US in 2023 as an easy-to-use, portable treatment option for acute migraine attacks, but was turned down in January 2024 due to issues with manufacturing data in Satsuma's marketing application which is a subsidiary of Japan's Shin Nippon Biomedical Laboratories (SNBL) said that Atzumi is also the first product to be approved based on its SMART intranasal drug delivery technology which combines a novel nasal delivery device with a proprietary powder formulation to deliver a dose of DHE that sticks to the nasal lining and enhances drug absorption Compared to liquid-based DHE nasal products – which include Impel Pharma's Trudhesa and Bausch Health's Migranal – Satsuma's product offers greater stability and a reduced tendency to drip out of the nose or down the back of the throat Trudhesa was launched onto the market in 2021 and Impel makes similar claims for its product over Migranal which has been on the US market for decades sales failed to gather much momentum and Impel filed for bankruptcy protection in 2023 A plan to liquidate the company was agreed last year with the sale of its assets to "stalking horse" company JN Bidco LLC for $17.5 million Satsuma now has an opportunity to stake a claim to the intranasal migraine segment and see if it can do better commercially with Atzumi – at one point analysts were discussing potential peak sales of $400 million a year – although the acute migraine market has become increasingly crowded with the launch of non-DHE options Those include Pfizer's nasally-administered CGRP inhibitor Zavzpret (zavegepant) – added as part of its $11.6 billion takeover of Biohaven in 2022 – plus a series of oral CGRP inhibitors used for acute migraine including Pfizer's Nurtec ODT (rimegepant) and AbbVie's Ubrelvy (ubrogepant) providing patients long-lasting effects and the unique ability to provide benefit even when taken late in a migraine attack," said Dr Stewart Tepper vice president of the New England Institute for Neurology and Headache in Stamford will offer patients ease of use combined with the important known DHE clinical advantages," he added Novo Nordisk has had its NDA for an oral formulation of Wegovy accepted by the FDA It would be the first obesity-targeted GLP-1 in pill form Click Therapeutics' digital therapeutic (DTx) for migraine prevention has been cleared by the FDA becoming the first treatment of its type in the US Understanding how to harness real-world data and digital insights is essential The importance of biosimilars only continues to grow driven by the potential savings they are able to deliver to healthcare systems Jonah Comstock welcomed back Alice Valder Curran to the podcast to pick apart Trump's Executive Order order piece by piece Developments in the oncology space in 2024 brought hope to both industry and patients The ESG in Life Sciences Summit West is coming to San Francisco The ISPE Singapore Affiliate Conference & Exhibition is one of the largest and most respected events for bio & pharmaceutical manufacturing professionals opinions and features on pharma and healthcare sent straight to your inbox on Tuesday 28th January @ 10 am ET - 3 pm GMT - 4 pm CET entitled ‘Health Trends 2025: Reimagining What's Possibl Sign up for email newsletters and Deep Dive Clinical-stage biopharma company Satsuma Pharmaceuticals and its corporate parent announced that they have received US Food and Drug Administration (FDA) approval for Atzumi (dihydroergotamine (DHE)) nasal powder for the acute treatment of migraine with or without aura in adults The approval was based on data from a Phase I pharmacokinetics trial and the Phase III ASCEN trial as well as high and sustainable levels of DHE plasma concentration Atzumi was shown to be safe in individuals with migraine with the drug providing pain relief within two hours in more than a third of the participants The North Carolina-based company's marketing application for Atzumi was previously rejected by the FDA last year The complete response letter cited chemistry but did not indicate any issues with the data or request any new clinical trials TwitterLinkedin Copyright © The Pharma Letter 2025   |   Headless Content Management with Blaze The FDA ap­proved a new nasal spray for mi­graines that was de­vel­oped by Sat­suma Phar­ma­ceu­ti­cals Get free access to a limited number of articles plus choose newsletters to get straight to your inbox Enter the email associated to with your Endpoints account and we'll send you a one-time login link (no password needed) and we'll send you a link to reset your password The link expires after 24 hours and can only be used once Sign up for free to read a limited number of articles each month Pick what newsletters get delivered to your inbox each week Want unlimited access? 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Design, CMS, Hosting & Web Development :: ePublishingCookie Settings The only approved DHE nasal powder addresses persistent limitations of existing DHE formulations including liquid nasal sprays and injectables and sustained DHE concentrations with low variability The drug device product addresses long-standing limitations associated with existing DHE formulations "The approval of [STS101] is a milestone to celebrate providing a new option for the acute treatment of migraine combining long-proven benefits of DHE with a patient-friendly and easy-to-use delivery system developed based on [the Satsuma parent company's] novel intranasal drug delivery platform technology," Ryoichi Nagata "DHE plays a unique clinical role in the acute treatment of migraine will offer patients ease of use combined with the important known DHE clinical advantages," Stewart J Tepper vice president of the New England Institute for Neurology and Headache The FDA approval of the 505(b)(2) New Drug Application for STS101 was based on data from 2 clinical studies, a phase 1 pharmacokinetics (PK) trial and the ASCEND phase 3 open-label single-use nasal device was evaluated over 18 months The 344 participants had a mean age of 40 years and reported migraine with or without aura expressed as 4 to 12 monthly migraine attacks and fewer than 15 headache days per month in the 3 months preceding screening Participants self-administered DHE powder as needed for migraine attacks with a maximum of 2 doses within 24 hours and up to 12 doses per month.2 Among the 47.4% reported migraine with aura and 31.7% reported allodynia approximately 19.9% required a second dose The most common treatment-emergent adverse events (TEAEs) were nasal discomfort (11.3%) Severe TEAEs occurred in only 2.6% of participants A total of 25.9% of participants experienced a TEAE considered related to study treatment and the rate of severe TEAEs was 0.2% per treated attack.2 The safety profile of STS101 was comparable to that of the previously available dihydroergotamine 1.45 mg liquid nasal spray and dizziness (4%) as common adverse events No new safety signals related to the novel powder formulation or delivery route were identified.2 It is the leading cause of disability among neurologic disorders in the US It is the second leading cause of disability worldwide in terms of time lost to disability and most common cause of disability among young women.3 "We believe that Atzumi will contribute to improving the quality of life of patients struggling for relief from these highly disabling problems," Nagata stated.1 Amyloid and Tau Biomarkers of Alzheimer Disease Found in Individuals with Other Dementias Biomarkers in a pattern characteristic of Alzheimer pathology were identified in unspecified dementia Distress Signals: How to Help a Clinician Colleague in Need "Primary Viewpoints," a podcast from Patient Care Online brings you an exclusive interview with Rebekah Bernard a family physician and national speaker on physician wellness Metabolic Syndrome Linked to Risk of Young Onset Dementia Authors found a dose-response relationship between MetS and dementia onset in the 4th decade; in those with all 5 components Primary Viewpoints Episode 19: Mobile Health Technology for Chronic Pain Management brings you an exclusive interview with Lynn Webster past president of the American Academy of Pain Medicine One in Three Cases of Dementia May be Attributable to Hearing Loss: Population-Based Study Interventions to protect or improve auditory health across the lifespan could be a cost-effective means of slowing the rapid rise of dementia in the US FDA Grants First-in-Class Marketing Authorization for Digital Therapeutic in Episodic Migraine Prevention CT-132 is a 12-week app-based intervention that uses validated behavioral techniques to modulate labile brain circuitry involved in migraine 609-716-7777 SATSUMA — The Livingston Parish Coroner's Office on Thursday identified a man killed in a fiery crash on Interstate 12 near Satsuma over the weekend. The coroner said 23-year-old Rory Craft was killed after the crash on I-12 eastbound WBRZ has reached out to the Livingston Parish Sheriff's Office for more information about what caused the crash 1/30Satsuma vs Bayside Baseball.st1{fill-rule:evenodd;clip-rule:evenodd;fill:#2a2a2a}By Mike Perrin | preps@al.comSatsuma rallied from a Friday loss on the road to beat Bayside Academy in a doubleheader opener on Saturday and then take the Class 4A Area 1 series tiebreaker – and the championship – with a 6-3 win Bayside beat the Gators 12-2 at home on Friday before Satsuma won Game 1 of the doubleheader 13-3 “It was an emotional series,” Satsuma coach Rodney Hicks said They never quit and it could have been easy to quit after losing Friday night but they showed up Saturday and fought their tail off to win the 4A Area 1 championship especially the eight seniors that lead this team.” Satsuma went 6-1 in April to push its record to 18-9 The Gators came from behind in the deciding game Bayside scored on back-to-back singles and a bases-loaded walk to take the lead on 3 hits in the first Satsuma scored on a pair of errors in the fifth inning to pull ahead 5-3 adding another run on an error in the sixth Darius Kupua and Cooper Crenshaw had 2 hits apiece for Satsuma Hunter Sullivan pitched 5 innings for the win Parker Sells came in relief for the final 6 outs to secure the victory University of South Alabama signee Cole Dean was 2-for-2 with a double for the Admirals and Amos McDaniel went 2-for-3 with an RBI Starter Will Fitzhugh gave up 3 earned runs on 4 hits with 3 strikeouts and a walk Dean allowed 3 unearned runs on 2 hits with 2 strikeouts and a walk in the final 3 innings the Gators used an 11-run fourth inning to roll over Bayside in the 5-inning rout pounded out 9 singles and coaxed 4 walks in the decisive inning The Gators went into the inning trailing 3-2 after scoring a pair of runs in the second and Bayside answering with 3 in the top of the fourth Matt Sullivan battled through a 7-pitch bases-loaded at-bat to single in Jake May and Cooper Brinkman The Gators pounded out 16 hits with every starter getting at least one Crenshaw was 3-for-4 with a double and 2 RBIs Braxton Byrd was 2-for-3 with an RBI and Ben Glen Micah Sullivan and KJ Austin all had 2 hits Kapua allowed 3 earned runs on 4 hits with 7 strikeouts and 4 walks for Satsuma Dean and Jack Callaway had doubles for the Admirals and Palmer Angermeier drove in a pair of runs allowing 5 earned runs on 9 hits with 5 strikeouts and 2 walks over 3.1 innings The Admirals scored 10 in the fourth to break open a 2-2 game Hannaman had a bases-loaded triple to deep center field off a 1-2 Tucker Hicks pitch The Bayside catcher also had a double and a single Noah Cain had a pair of singles and drove in 2 runs for Bayside Grady Stokes gave up 2 runs on 6 hits with 9 strikeouts in 5 innings to get the win Glen drove in both Gators’ runs with a 2-out single to knot the game at 2 in the fourth inning Tucker Hicks had a pair of hits and Crenshaw had a double allowing 12 runs – 4 earned – on 8 hits with 4 walks over 3.1 innings Luke’s on Monday while Bayside Academy will host Bayshore Christian In other high school spring sports from around the state over the weekend: Area 1 doubleheader on Friday to wrap up the 3-game series at Mary G Baker (15-14) had whipped the Vikings 14-4 on Thursday Tate Graham led the Hornets with 3 singles and drove in Yadiel Orellano to start a 3-run rally in the third inning Orellano and Spencer Stewart finished with 2 hits apiece in the win allowing 4 runs – 2 earned – on 3 hits in 3 innings Pierce Rogers shut out MGM on 3 hits with 3 strikeouts and 3 walks in 4 innings Catcher TJ Wood was 3-for-3 for MGM with an RBI and DJ Broughton had a double in the loss allowing 6 runs – 4 earned – on 10 hits with 4 strikeouts and 2 walks the Hornets scored in the final four innings of the 5-inning game as Graham pitched a 2-hitter with 7 strikeouts and a walk in 5 innings The sophomore also had a double and 2 RBIs as Baker extended its winning streak to five games Rogers was 3-for-4 with 2 RBIs an Mizelle had 2 hits in 3 at-bats with 2 RBIs Anderson Murray and Jeremy Gandy had hits for Mary G giving up 5 runs – 1 earned – on 6 hits with 3 strikeouts and a walk Luke’s scored 8 runs in the top of the seventh to rally from a 5-4 deficit and bounce back from a Friday loss to the Eagles Jeremy Menhennett’s RBI single tied the game at 5-5 Conner Moseley walked to drive in the go-ahead run for the Wildcats (16-9) Russ Warner provided the biggest blow of the inning with a 3-run double Campbell Tillman was 2-for-4 with 2 runs scored Andrew Thomas got the win with 2 innings of relief of Menhennett Miles Bechtel-Scott – the fourth of five pitchers – took the loss for Bayshore Jack Malone went 2-for-3 with a pair of RBIs a pair of walks and a run scored for the Eagles (12-13) Paul’s swept a pair of games from rival Mobile Christian to clinch the Area 2 championship the Saints (18-8-1) scored a pair of runs in the bottom of the seventh for the win Paul’s tied it on John Stowers’ sacrifice fly and won it on an RBI single by Brooks McDonald Bradley Irish went the distance for the win Starter Maddox McKinion took the loss for the Leopards Bryce Rivers had 2 hits for Mobile Christian Paul’s scored the winning run in the top of the eighth on Hudson Farnell’s RBI single McLeod was 2-for-3 with 4 runs scored for the Saints Dylan Peters took the loss in relief of Michael Harper McGill-Toolen used a pair of pitchers to shut out Baldwin County in the opener Mitchell Adams started and pitched 3 innings Cullen Patrick pitched the final 4 innings The Yellow Jackets (20-8) scored single runs in the second Jack Lenaghan and Christian Tover had RBIs Coen Lambeth limited the Jackets to a hit and struck out 9 in a complete game The Tigers scored the only run of the game in the third following Braydon Bryars’ single Tripp Crawford – the first of three McGill pitchers – took the loss The Dolphins scored 22 runs on 21 hits in a sweep of Class 6A No John Will Nix limited the Toros to a hit in 5 innings Price Stephens drove in 3 runs for Gulf Shores Jacob O’Bryan and Trendon Beebe drove in 2 runs each Levi Howard was 2-for-3 with 2 runs scored Lakelon Ray had Spanish Fort’s only hit and Newton Gardner took the loss on the mound Gulf Shores scored 5 times in the bottom of the first and led 9-3 after 4 innings on the way to the win Tres Moore and Woods McElroy each drove in 2 Howard started on the mound and got the win Brandon Pegueros took the loss for Spanish Fort Ray and Damien Tate each had a pair of hits for the Toros 1/5Hazel Green at Buckhorn baseballHUNTSVILLE/TENNESSEE VALLEY The Bucks edged Hazel Green in 9 innings at home on Saturday to sweep the two-game Class 6A Area 16 series after three Buckhorn pitchers no-hit the Trojans 9-2 on Friday The Bucks earned the area championship for the second straight season Tye Burress drove in the winning run on Saturday singling in pinch-runner Aidyn Brown – in for Andrew Oelike who had walked – advanced on another walk and went to third on a wild pitch with Burress singling in 2 of 3 runs in the first and Braden Abernathy driving in another run in the second with a single to left field Hazel Green scored single runs in the third pushed across 2 in the top of the seventh to send the game into extra innings Abernathy went 4-for-5 with a triple and 2 RBIs for Buckhorn He shut out the Trojans on 2 hits with 3 strikeouts and 2 walks over 3 innings Starter Parker Turley gave up 2 runs – 1 earned – on 4 hits with 2 strikeouts in 3 innings Peyton Joiner allowed 3 runs – 2 earned – on 2 hits with 2 strikeouts and 2 walks in 3 innings Israel Navarro was 2-for-5 with 3 RBIs for Hazel Green and Jaden Charles was 2-for-3 allowing an earned run on 1 hit with a strikeout and 2 walks in 1.1 innings’ work Starter Elijah Steele gave up 5 runs – 2 earned – on 6 hits with 5 strikeouts and 7 walks in 7 innings starter Oelke and relievers Joiner and Jacob Gentle no-hit the Trojans in the 7-inning game allowing 2 runs – 1 earned – with 5 walks in 6.1 innings Joiner struck out 1 and walked 2 of the 3 batters he faced and Gentle walked a batter before closing out Hazel Green Oelke also helped his cause at the plate with a home run and a double as he went 3-for-4 with 5 RBIs Abernathy was 4-for-5 with an RBI and 3 runs scored in the win Starter Colton Clark took the loss for Hazel Green allowing 4 earned runs on 6 hits with 8 strikeouts and 5 walks in 5.1 innings The second-ranked Patriots swept a doubleheader at home over Florence on Saturday to earn all three wins in the Class 7A Bob Jones also won the series opener 5-0 at Florence on Thursday Florence broke on top 1-0 in the top of the first inning before the Patriots pushed across 2 runs in the bottom of the inning The Falcons tied the game in the fifth when Auston Klotzbach raced home as part of a double steal but Bob Jones put together three straight singles – by Zack Johnson Dillon Adkins and Cole Spanier – to regain the lead at 3-2 The home team scored 3 with 2 outs in the sixth on a dropped third strike and a passed ball to back-to-back batters Florence answered with a 2-out run on an outfield error allowing 3 runs – 2 earned – on 8 hits with 5 strikeouts and a walk Johnson was 2-for-3 and Martin was 2-for-4 with and RBI Eli Martin went 2-for-4 for Florence and Cooper Thomaston had a double allowing 6 runs – 3 earned – on 8 hits with 7 strikeouts and 5 walks over 5.2 innings Johnson homered and doubled and Tanner Hermesch had a home run as Bob Jones scored in all 6 innings of the game Johnson was 2-for-3 with 3 RBIs and 2 runs scored Hammonds was 2-for-3 and Elijah Degante was 2-for-2 with a double Starting pitcher Martin threw a 1-hit shutout with 11 strikeouts and 2 walks over 5 innings Joshua Wilhide struck out 2 of the 3 batters he faced in the sixth allowing 6 earned runs on 5 hits with 2 strikeouts and 4 walks over 3 innings The sixth-ranked Class 6A Patriots ran their record to 26-6 with the shutout at 5A No Southern Union Community College signee Jack Ross struck out 8 in a complete-game performance allowing 2 hits with no walks for Homewood George Brockwell had a run-scoring 2-out single in the top of the third inning for the Patriots and Ross’ homer made it 2-0 in the sixth a stolen base and a single by Will Dobbins pinch-hitter Ben Roberts brought home the final run on a squeeze bunt Ross retired six in a row to close out the win allowing 3 runs – 2 earned – on 5 hits with 3 strikeouts and a walk over 5.1 innings Sage Bennett and Tyler Pierce had a single apiece for the Pirates Alabama Christian swept doubleheader on the road on Friday to wrap up three wins in the Class 3A ACA opened the series with an 11-3 win at home Alabama Christian scored at least 2 runs in the first four of the 5-inning game Bryson Dabney and Ethan Dabney had a double each in the win Both were 3-for-3 at the plate with Bryson Dabney driving in 7 runs Jackson Burton went 2-for-3 with 4 RBIs and 3 runs scored Jackson McGuire earned the complete-game win allowing an earned run on 3 hits with 4 strikeouts and a walk Oscar Fiore and Andrew Hosein had hits with Hosein picking up an RBI for Montgomery Academy allowing 8 runs – 6 earned – on 5 hits with a strikeout and 5 walks allowed 6 earned runs on 4 hits with 3 strikeouts and 2 walks over 1.2 innings’ work ACA jumped to a 7-0 lead in the top of the first inning and held off Montgomery Academy’s late rally 1 in the sixth and 3 in the bottom of the seventh McBride drove in a pair of runs on a double with 1 out in the seventh and an out later William Marks singled in a run and Fiore drove in another with a single to cut the lead to 12-11 Jacob Heilman got the final out with a strikeout 9 hitter Ethan Dabney went 2-for-3 with a triple and 3 RBIs for Alabama Christian Mason Roosendaal was 2-for-3 with an RBI and Mac Moorer had a pair of RBIs allowing 6 earned runs on 5 hits with 5 strikeouts and 5 walks over 4.1 innings had 3 hits and a pair of RBIs each for Montgomery Academy McBride was 2-for-3 with a double and 2 RBIs and Hosein was 2-for-2 with a double and 3 runs scored allowing 7 runs – 6 earned – on 3 hits with a strikeout and 3 walks Montgomery Academy (12-10) wraps up its season at home on Monday at 4:30 p.m Oak Mountain's Adrian Gutierrez leaps for a header during the Westminster-Oak Mountain at Oak Mountain boys soccer game in Birmingham (Vasha Hunt | preps@al.com)(Vasha Hunt | preps@al.com) The top-ranked Class 7A Eagles rolled over Class 5A No 1 Guntersville and ran their record to 23-0 and their unbeaten streak to 54 games in the Border Wars quad match at Fort Payne’s Wildcat Stadium on Saturday Oak Mountain held AHSAA all-time leading scorer AJ Shumate – and all of his teammates – without a shot in the rout led the back line in stifling Guntersville’s attack Goalkeeper Owen Wells picked up the shutout – Oak Mountain’s sixth straight and 15th on the season Sam Collins scored 5 goals for Oak Mountain and Gabe Capocci scored twice in the rout Luke Jovanovich and Gerardo Rodriguez both had a goal and 2 assists Shumate came into the game with 197 career goals for the Wildcats after getting a hat trick in a win over Randolph on Tuesday and a pair of goals in a 4-1 win over Scottsboro in the Border Wars Oak Mountain blanked host Fort Payne 8-0 on Friday as Collins recorded a hat trick Jovanovich finished with 2 goals and 2 assists for the Eagles Nate Wright and Michael Dennis also had a goal apiece Alexander Chiadez had a save in the shutout Valentino Garcia scored a second-half goal to help Class 7A No 9 Baker to the win over McGill-Toolen and giving the Hornets a season sweep over the Yellow Jackets Garcia’s goal came 21 minutes into the second half and gave the Hornets an insurance goal Baker had broken on top on a McGill own goal earlier in the half Naith Allen turned in the clean sheet for Baker Baker (15-5-1) closes out the regular season at Mary G Montgomery on Thursday and will open the playoffs at Fairhope Montgomery Academy’s John Alford and Jackson Brown won their 100th match as a doubles team for the Eagles in a 7-2 win over Hillcrest-Tuscaloosa in the regular-season finale The Eagles pushed their season record to 18-1 with the win Liam Baker and Duncan McInnes won singles matches for MA Yang and Bo Johnston also picked up a win in doubles Section 2 tournament begins on Monday at Lagoon Park Tennis Center in Montgomery Top-ranked Class 7A Thompson blanked 4A No 1 Orange Beach in a tournament game at the Chelsea Sports Complex on Saturday Thompson edged Auburn 3-2 after opening the tournament with a 4-2 loss to 6A No the Warriors scored a pair of runs in the top of the first and 2 more in the top of the sixth and Kadyn Bush and Aubree Hooks blanked the Makos on 5 hits Hooks retired the three batters she faced in the seventh after her entry with 2 outs in the bottom of the sixth when Orange Beach’s Teagan Revette was called out for leaving first base early Both teams finished with 5 hits with Thompson committing a pair of errors and Orange Beach having 1 Aubrey Bauer went 2-for-4 for the Warriors and Hannah Hobbs was 1-for-3 with 2 RBIs allowing 4 runs – 2 earned – on 5 hits with 5 strikeouts and 2 walks Kathryn King was 2-for-3 to lead the Makos Bush and Morgan Adolphus had a double each in Thompson’s win over Helena The Warriors had 9 hits on the day with Adolphus going 2-for-3 with a pair of RBIs and Hobbs driving in 2 runs giving up an unearned run on 3 hits with 8 strikeouts and 3 walks over 5.2 innings Autumn Ingle struck out a batter in 1.1 innings Lily Abernathy had a double in 2 at-bats with an RBI for Helena allowing 5 runs – 3 earned – on 2 hits with a pair of walks in 4.1 innings Thompson earned a walk-off win when Hooks smacked a 2-out single to right field to drive in Olivia Tindell Adolphus was 2-for-3 with a double with Tindell and Bush picking up an RBI each Ingle pitched the final inning and picked up the win allowing a hit with a strikeout and a walk Starter Alexia Kelley gave up no runs on 3 hits with a strikeout in 4 innings allowing 2 earned runs with 2 strikeouts and 2 walks Pressley Slaton took the loss for Alexandria allowing 3 runs – 2 earned – on 7 hits with a strikeout and 3 walks over 7 innings Leadoff hitter Charlee Parris had a triple in 3 at-bats and Allyssa Hunt was 2-for-3 with a double and 2 RBIs outhitting the Tigers 7-3 with Kelley retiring the side in order in the top of the seventh to preserve the win The Warriors scored a run in the third and 2 in the fourth to carry a 3-0 lead into the top of the sixth when Auburn pushed across 2 runs Alivia Harris led off the inning with a single went to second on a hit by Daley Alsobrook and scored on a double by Abigail Helms Alsobrook took third on Helms’ double and scored on an error on the Thompson catcher Mallory Flournoy went 2-for-2 with 2 RBIs for Thompson Bush struck out 7 in 6 innings for the Warriors allowing 2 runs – 1 earned – on 3 hits with 3 walks Kelley struck out 2 of the three batters she faced in the seventh allowing 3 earned runs on 7 hits with a strikeout and a walk 2 Chelsea scored a pair of runs in the top of the seventh to knock off 7A No 1 Thompson on Friday in a tournament hosted by the Hornets Lorelei Beck ripped a 1-out line drive to left field to drive in Olivia Palfreeman and Kaitlin Hopson to give Chelsea the winning runs Hopson went 2-for-4 with an RBI and Beck was 2-for-4 with 3 RBIs in the win Madeline Kelley finished 2-for-3 with a double and Sadie Wilson had a double allowing 2 earned runs on 7 hits with 2 strikeouts and a walk in 6 innings Emma Parmley relieved Beck after Blakely Davis walked to lead off the seventh inducing a double play and a ground out to end the game Kadyn Bush doubled in 3 at-bats and Ansley Haynes also had a double in the loss Autumn Ingle took the loss in relief of Hooks allowing an earned run on 3 hits with 4 strikeouts and 2 walks in 2 innings Hooks gave up 2 runs – 1 earned – on 5 hits with 9 strikeouts and 3 walks in 5 innings The Wildcats earned the weather-shortened win over Decatur Heritage in 4 innings in the Cullman Pre-State Tournament Starter Carleigh Gothart struck out 5 of the 7 batters she faced over 2 scoreless innings and Stella Ward gave up a hit and no runs in an inning for Westminster Christian Slaten went 2-for-2 with 2 RBIs for the winners The Wildcats (12-9) will host North Jackson on Tuesday The second-ranked Wildcats wrapped up Class 5A Area 16 play with a mercy rule shortened game on Friday Westminster Christian out-shot the Tigers 38-2 Freshman Ava Martinez poured in 6 goals to lead Westminster Alex Menin and Carson Heater had a goal each Ardmore’s goal was the first given up by Westminster (11-3-1) in area play this season The Panthers got a pair of goals from Addison Sutton in the home stalemate with Charles Henderson on Friday Mimi Szeker had an assist for Prattville Christian PCA (4-8-2) will travel to Autauga Academy on Monday Some information in this report is from GameChanger Media Editor’s Note: To report highlights to AL.com, please email preps@al.com following your games Reports must come from coaches or team statisticians and no later than 10:30 a.m Use of and/or registration on any portion of this site constitutes acceptance of our User Agreement, (updated 8/1/2024) and acknowledgement of our Privacy Policy, and Your Privacy Choices and Rights (updated 1/1/2025) © 2025 Advance Local Media LLC. All rights reserved (About Us) except with the prior written permission of Advance Local Community Rules apply to all content you upload or otherwise submit to this site YouTube's privacy policy is available here and YouTube's terms of service is available here Ad Choices Falling tree limbs in Birmingham kills one person The Missing Child Alert has been cancelled The Satsuma Police Department is asking for the public's assistance in locating Aiden Lee Davis Aiden Lee Davis is a 17-year-old white male and possibly carrying a backpack in the area of Malaga Drive in Satsuma If anyone has any information regarding the whereabouts of Aiden Davis please contact the Satsuma Police Department at (251) 675-0151 or call 911 2024 /PRNewswire/ -- Satsuma Pharmaceuticals Food and Drug Administration (FDA) has accepted for review a resubmission to original new drug application (NDA) for the investigational product STS101 (dihydroergotamine nasal powder) for the acute treatment of migraine with or without aura as a complete response to their January 2024 action letter The Prescription Drug User Fee Act (PDUFA) date is set as April 30 Satsuma Pharmaceuticals and SNBL Receive  FDA Acceptance of Resubmission of STS101  for the Acute Treatment of Migraine Almost 40 million people in the United States suffer from migraine especially among working women in their 20s to 40s market for acute migraine medications is estimated to be over USD 1.0 Billion a wholly-owned subsidiary of Shin Nippon Biomedical Laboratories is a late-stage biopharmaceutical company that is currently seeking regulatory approval from the U.S investigational therapeutic product for the acute treatment of migraine STS101 is a unique and proprietary nasal powder formulation of the well-established anti-migraine drug administered via Satsuma's proprietary nasal delivery device STS101 is designed to provide patients the combination of quick and convenient self-administration Satsuma's nasal powder DHE formulation has demonstrated fast absorption sustained DHE plasma levels over time and low dose-to-dose variability Satsuma is headquartered in Research Triangle Park, North Carolina. For further information, please visit www.satsumarx.com Inquiries:Satsuma Pharmaceuticals, Inc.E-mail: [email protected]Website: www.satsumarx.com a late-stage biopharmaceutical company dedicated to bringing novel treatments to people who suffer from migraine and.. How to watch Alabama high school softball: Satsuma vs How to watch St. Michael vs. Satsuma softballSt. Michael and Satsuma will hit the diamond on Monday, April 28, at 10 a.m. CT. Don't miss out on any of the action with NFHS Network The NFHS Network gives you access to live high school sports around the country Follow your favorite team and never miss a game Want to track your alma mater, local team or family member's school throughout the playoffs? NFHS Network has high school softball streaming live plus on-demand replays and highlights of all the action from thousands of schools across America Watch Satsuma vs. St. Michael on NFHS Network! All NFHS Network events are available to watch online at NFHS Network and through the NFHS Network Mobile Apps for iOS and Android and TV Apps for ROKU SATSUMA - One person died after a crash and vehicle fire on I-12 East The right two lanes are blocked and congestion is approaching Walker South Road Baxter's 4th Grade Class - Lee Elementary Herrington's 5th Grade Class - Lee Elementary Rabren's 4th Grade Class - Lee Elementary Extended Search Case resembles March death of 4-year-old found in water near home Putnam County Sheriff's Office marine unit deputies search the canal near Gabriel Paguio's home Tuesday afternoon The search for a missing child ended Tuesday after two hours when his body was discovered in a canal near his home Tuesday after going missing from his Clearwater Road home shortly after 3 p.m. Putnam County Sheriff’s Office spokeswoman Allison Waters-Merritt said.  Paguio is believed to have had special needs His family had been looking into getting an official diagnosis but had not yet received it Paguio’s family had been searching for the child for about 20 minutes before they called 911 around 3:30 p.m. K-9s and dive team were dispatched to search for the child.  we ask for you to say a prayer for the family,” Sheriff Gator DeLoach said Tuesday in a Facebook statement “No family should undergo the tragedy of losing their child and we ask for comfort from our community to support them as they navigate the difficult journey ahead.” Authorities are continuing to investigate the circumstances surrounding the boy's death.  Paguio is the second child with special needs to be found dead in a body of water this year was found under a dock near his Front Street home in Welaka in March and was determined to have accidentally drowned Newstead was nonverbal and diagnosed as having autism While sheriff’s office deputies are trained to work with people who are nonverbal or have been diagnosed with mental illnesses caregivers can go a step further and complete a scent kit People will receive a boxed kit that includes gloves instructions to secure the scent and a computer flash drive The sheriff’s office’s K-9 unit is trained to use the scent kit to track the person associated with the smell The kit can retain a person’s scent for 10 years call the sheriff’s office’s victim’s assistance program at 386-329-1282 Read Palatka Daily News, Palatka, Florida This website is using a security service to protect itself from online attacks The action you just performed triggered the security solution There are several actions that could trigger this block including submitting a certain word or phrase You can email the site owner to let them know you were blocked Please include what you were doing when this page came up and the Cloudflare Ray ID found at the bottom of this page Sign up for our daily Newsletter and stay up to date with all the latest news You are receiving this pop-up because this is the first time you are visiting our site You are using software which is blocking our advertisements (adblocker) we are relying on revenues from our banners So please disable your adblocker and reload the page to continue using this site.Thanks known for their adaptability in cold-hardy citrus regions face challenges in North Florida and South Georgia due to limited shelf life executive director of the Georgia Citrus Association to reconsider their cultivation strategies Savelle plans to remove 400 of her 1,000 satsuma trees accounting for about 40% of her production Market conditions have led to a reassessment of satsuma cultivation who are going to remove some of their satsuma trees," said Savelle "We're doing it because we're pivoting to an agritourism model 'I'm not going to get myself in a situation where I've got this overabundance.'" The limited market window was shortened last season due to late fruit maturity too fast,' and the market could not absorb it." Future strategies may involve diversifying crops and exploring new markets emphasizing the importance of timing in citrus production "People are saying that maybe we need to be growing a product that will hold onto the tree for a longer period of time," she stated she warned against producing citrus that matures during freezing periods Source: Citrus Industry Frontpage photo: © Juriah Mosin | Dreamstime FreshPublishers © 2005-2025 FreshPlaza.com Milne's Kindergarten Class - Lee Elementary Maria Estelle Saylor sings "Say Amen" during a vigil Wednesday in Satsuma to mourn Gabriel Paguio who died Tuesday after going missing from his Clearwater Road home SATSUMA – Neighbors and friends held candles and sang earlier this week to honor a local child whose body was found earlier this week near his Clearwater Road home.  A thunderstorm held off just long enough for residents to partake in a vigil for Gabriel Paguio who went missing from his home Tuesday.  Putnam County Sheriff’s Office deputies found the child dead in a canal near his residence after searching for two hours.  said she and her family had only lived in the area for a few years but she received help from everyone around her when Paguio went missing.  “When I tell you that everybody from Dollar General back was out in full force yesterday while we were searching that was not a lie,” Corson said Wednesday evening Paugio’s family had searched for him for 20 minutes with no luck before calling authorities around 3:30 p.m sheriff’s office spokeswoman Allison Waters-Merritt said.  K-9 deputies and dive team took to the canal behind the Paguio family’s home to look for the child The people who organized the vigil didn’t know the family but wanted to lift up the family in prayer.  “I just appreciate everything you all have done,” Corson told the crowd of about 30 people “People I didn’t even know reached out that I would now call friends.” Corson said deputies found him in the water directly behind her home.  “A lot of this was the devil,” Corson said about her grandson’s death “He’s going to target (children) because they’re new and they’re fresh After praying aloud to help the family grieve the crowd began singing “Amazing Grace” and comforted the family.  Welaka Councilwoman Kathy Washington attended the vigil to support Paguio’s mother who recently started leading the women’s Bible study three weeks ago at Dunns Creek Community Church.  “I feel like there’s a place and time that God has us all together beforehand,” Washington said.  Paguio is the second child to be found dead this year in Putnam County in a body of water Washington said Paguio’s death stirred up memories of Mason Newstead who went missing from his Welaka home March 21 and was found dead nearby in the St and although Paguio hadn’t been diagnosed with any ailment “My heart goes out to (Paguio’s mother) and the family because you know we just lost someone in Welaka.” Musgrove's 6th Grade Class - Lee Elementary Douville's 2nd Grade Class - Lee Elementary Freeman's 2nd Grade Class - Lee Elementary Johnston's 3rd Grade Class - Lee Elementary a two-vehicle crash that occurred at approximately 7:49 a.m was fatally injured when the 1995 Ford F800 he was driving struck the 2024 Peterbilt tractor-trailer driven by Jason K Moore was not using a seat belt at the time of the crash was injured and transported to University of South Alabama Hospital in Mobile for treatment Bond's 4th Grade Class - Lee Elementary Allen's 5th Grade Class - Lee Elementary Rouss' 6th Grade Class - Lee Elementary