This section highlights FDA-related milestones and regulatory updates for drugs developed by Axsome Therapeutics (AXSM).
Over the past two years, Axsome Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Auvelity, AXS-05, AXS-07, AXS-12, AXS-14, solriamfetol, and SYMBRAVO. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Auvelity - FDA Regulatory Timeline and Events
Auvelity is a drug developed by Axsome Therapeutics for the following indication: Patients with Major Depressive Disorder.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Auvelity
- Announced Date:
- May 28, 2025
- Indication:
- Patients with Major Depressive Disorder
Announcement
Axsome Therapeutics, announced presentations from three of its innovative neuroscience programs at the American Society of Clinical Psychopharmacology (ASCP) 2025 Annual Meeting, being held from May 27-30 in Scottsdale, Arizona.Inc.
AI Summary
Axsome Therapeutics announced that it will share scientific insights from three innovative neuroscience programs at the upcoming ASCP 2025 Annual Meeting in Scottsdale, Arizona, from May 27-30. One presentation, led by Dr. Anita Clayton, will focus on initiating treatment with AUVELITY for adults with major depressive disorder. A second presentation will address a phase 3 study evaluating the efficacy and safety of AXS‐05 in managing agitation in Alzheimer’s disease. The third session will explore the use of solriamfetol to tackle excessive daytime sleepiness in patients with narcolepsy and obstructive sleep apnea, including those experiencing anxiety and depression. These presentations provide a platform to highlight Axsome’s cutting-edge research and potential future treatment options in neuroscience. They reflect the company’s commitment to advancing therapeutic innovations and improving outcomes for patients with central nervous system disorders.
Read Announcement- Drug:
- Auvelity
- Announced Date:
- February 10, 2025
- Indication:
- Patients with Major Depressive Disorder
Announcement
Axsome Therapeutics, Inc. announced that it has entered into a settlement agreement with Teva Pharmaceuticals, Inc.
AI Summary
Axsome Therapeutics, Inc. announced that it has reached a settlement agreement with Teva Pharmaceuticals, Inc. The agreement settles all patent litigation involving Axsome’s product AUVELITY®, which is used to treat central nervous system disorders. Teva had submitted an Abbreviated New Drug Application seeking to market a generic version of AUVELITY before Axsome’s patents expired. Under the settlement, Teva will receive a license to sell its generic version starting on or after September 30, 2038 if pediatric exclusivity is not granted, or on or after March 31, 2039 if it is granted. This arrangement, subject to FDA approval and typical conditions, ends all ongoing litigation in the U.S. District Court for the District of New Jersey. Axsome stated that the settlement highlights the strength of its intellectual property and commitment to developing innovative treatments for central nervous system disorders.
Read Announcement- Drug:
- Auvelity
- Announced Date:
- May 28, 2024
- Indication:
- Patients with Major Depressive Disorder
Announcement
Axsome Therapeutics, Inc. announced that data from its industry-leading portfolio of novel products for CNS disorders will be presented at the 2024 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, being held May 28-31, 2024, in Miami Beach, Florida.
AI Summary
Axsome Therapeutics recently announced that it will present new data on its novel products for central nervous system (CNS) disorders at the 2024 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting. The event will take place from May 28-31, 2024, in Miami Beach, Florida. The company’s presentations will include findings from post-hoc analyses of Auvelity® showing significant improvements in anhedonia—a key symptom of major depressive disorder—and related enhancements in daily functioning. Additionally, Axsome will share clinical data on AXS-05, focusing on its potential to treat agitation in Alzheimer’s disease patients. This forum at ASCP highlights Axsome’s ongoing commitment to developing industry-leading therapeutic options for challenging CNS conditions, aiming to improve patient outcomes by providing innovative and effective treatment strategies.
Read Announcement
AXS-05 - FDA Regulatory Timeline and Events
AXS-05 is a drug developed by Axsome Therapeutics for the following indication: Major Depressive Disorder.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AXS-05
- Announced Date:
- April 4, 2025
- Indication:
- Major Depressive Disorder
Announcement
Axsome Therapeutics, Inc announced multiple presentations spanning its innovative, industry-leading psychiatry and neurology portfolio at the 2025 American Academy of Neurology (AAN) Annual Meeting, being held April 5-9 in San Diego, California..
AI Summary
Axsome Therapeutics, Inc. announced that it will present several key sessions at the 2025 American Academy of Neurology Annual Meeting in San Diego, California, scheduled for April 5–9. The company is showcasing its innovative portfolio in psychiatry and neurology, emphasizing groundbreaking treatments for central nervous system disorders.
Notably, one featured presentation is a late-breaking oral session revealing positive results from the pivotal ACCORD-2 Phase 3 trial of AXS-05 in Alzheimer’s disease agitation. Additional sessions will include top-line data from the Phase 3 SYMPHONY trial evaluating AXS-12 for narcolepsy, along with a network meta-analysis comparing the efficacy of SYMBRAVO with oral CGRPs for acute migraine treatment. These presentations underscore Axsome’s commitment to advancing treatment options for serious neurological conditions.
Read Announcement- Drug:
- AXS-05
- Announced Date:
- March 3, 2025
- Indication:
- Major Depressive Disorder
Announcement
Axsome Therapeutics, Inc announced that it has received formal pre-New Drug Application (NDA) meeting minutes from the U.S. Food and Drug Administration (FDA) supporting a supplemental NDA (sNDA) submission for AXS-05 in Alzheimer's disease agitation..
AI Summary
Axsome Therapeutics announced that it has received formal pre-NDA meeting minutes from the U.S. Food and Drug Administration (FDA) related to its upcoming supplemental NDA (sNDA) submission for AXS-05 in Alzheimer’s disease agitation. The FDA meeting confirmed the proposed content, format, and both clinical and nonclinical requirements for the submission, indicating that the company’s data package is sufficient for moving forward with the application. AXS-05, an investigational drug combining dextromethorphan and bupropion, is being developed to address agitation in Alzheimer’s patients—a condition with very limited treatment options. Axsome plans to submit the sNDA in the third quarter of 2025, and, given the Breakthrough Therapy designation for this indication, the application will be eligible for Priority Review. This development represents an important step toward providing a new treatment option for patients suffering from Alzheimer's disease agitation.
Read Announcement- Drug:
- AXS-05
- Announced Date:
- December 30, 2024
- Indication:
- Major Depressive Disorder
Announcement
Axsome Therapeutics, Inc. announced the successful completion of its Phase 3 clinical program evaluating AXS-05 (dextromethorphan-bupropion), a novel, oral, investigational NMDA receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor, in Alzheimer's disease agitation, and results of the ACCORD-2, ADVANCE-2, and long-term safety trials in this indication.
AI Summary
Axsome Therapeutics announced the successful completion of its Phase 3 clinical program for AXS-05, a novel oral agent targeting Alzheimer’s disease agitation. In the ACCORD-2 trial, AXS-05 met its primary endpoint by significantly delaying the time to relapse of agitation compared to placebo (p=0.001, 3.6-fold reduction in risk). It also achieved a key secondary endpoint in preventing relapse, while significantly reducing the worsening of overall Alzheimer’s disease severity (p<0.001). Although the ADVANCE-2 trial did not reach statistical significance on its primary endpoint, the results still numerically favored AXS-05 over placebo for both primary and secondary measures. Additionally, long-term safety trials, with patients treated for 6 to 12 months, confirmed that AXS-05 was well tolerated without increased risks of falls, cognitive decline, or sedation. Based on these promising results, the company plans to submit an NDA to the FDA in the second half of 2025.
Read Announcement- Drug:
- AXS-05
- Announced Date:
- April 15, 2024
- Indication:
- Major Depressive Disorder
Announcement
Axsome Therapeutics, Inc. announced presentations highlighting its innovative psychiatry and neurology pipeline at the American Academy of Neurology (AAN) 2024 annual meeting, being held April 13-18, 2024, in Denver, Colorado.
AI Summary
Axsome Therapeutics, Inc. announced that it will present data on its innovative psychiatry and neurology pipeline at the American Academy of Neurology (AAN) 2024 annual meeting in Denver, Colorado, from April 13-18, 2024. The presentations will showcase new research on several of its product candidates for central nervous system disorders.
Key highlights include an oral presentation featuring data from the ACCORD Phase 3 trial of AXS-05, which is being studied for agitation associated with Alzheimer’s disease. Additionally, the company will share new pooled efficacy data from the MOMENTUM and INTERCEPT Phase 3 trials of AXS-07 for migraine treatment. There will also be presentations on the benefits of solriamfetol, focusing on improvements in cognition and wake-promoting effects. These presentations underline the company’s commitment to developing novel treatments for patients with CNS conditions.
Read Announcement
AXS-07 - FDA Regulatory Timeline and Events
AXS-07 is a drug developed by Axsome Therapeutics for the following indication: Acute Treatment of Migraine.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AXS-07
- Announced Date:
- September 4, 2024
- Indication:
- Acute Treatment of Migraine
Announcement
Axsome Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the Company's New Drug Application (NDA) for AXS-07 for the acute treatment of migraine.
AI Summary
Axsome Therapeutics announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of its New Drug Application (NDA) for AXS-07. This medication is designed for the acute treatment of migraine, a condition that affects millions and can cause severe head pain along with nausea and sensitivity to light and sound. The FDA has classified the resubmission as a Class 2 submission and set a Prescription Drug User Fee Act (PDUFA) goal date for January 31, 2025. This step marks an important milestone for AXS-07, which combines MoSEIC™ meloxicam with rizatriptan in hopes of providing rapid and consistent migraine relief. The company aims to address the high demand among patients who are looking for treatments that work faster and reduce the chances of migraine symptoms coming back.
Read Announcement- Drug:
- AXS-07
- Announced Date:
- September 4, 2024
- Estimated Event Date Range:
- January 25, 2025 - January 25, 2025
- Target Action Date:
- January 25, 2025
- Indication:
- Acute Treatment of Migraine
Announcement
Axsome Therapeutics, Inc announced that The FDA designated the resubmission as a Class 2 resubmission and set a Prescription Drug User Fee Act (PDUFA) action goal date of January 31, 2025.
AI Summary
Axsome Therapeutics announced that the FDA has given its New Drug Application (NDA) resubmission for AXS-07 a Class 2 designation. This means that the agency has reviewed the resubmission and determined that it meets certain review criteria. Additionally, the FDA has set a Prescription Drug User Fee Act (PDUFA) action goal date of January 31, 2025. This goal date is when the agency aims to complete its review and make a decision regarding the application. AXS-07 is being developed as a new treatment option for acute migraine attacks. The company hopes that this designation and the upcoming review decision will pave the way for providing a faster, more consistent, and reliable treatment for migraine sufferers, addressing the unmet needs of many who do not find current therapies satisfactory.
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AXS-12 - FDA Regulatory Timeline and Events
AXS-12 is a drug developed by Axsome Therapeutics for the following indication: Narcolepsy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AXS-12
- Announced Date:
- June 11, 2025
- Indication:
- Narcolepsy
Announcement
Axsome Therapeutics, Inc. announced seven presentations, including two featured oral plenary sessions, on AXS-12 and solriamfetol, at SLEEP 2025, the 39th annual meeting of the Associated Professional Sleep Societies (APSS), being held June 8-11, 2025, in Seattle, Washington.
AI Summary
Axsome Therapeutics, Inc. announced it will present seven research studies at SLEEP 2025, the 39th annual meeting of the Associated Professional Sleep Societies in Seattle, Washington, from June 8–11, 2025. Among these presentations are two featured oral plenary sessions that will focus on AXS-12 and solriamfetol. The AXS-12 sessions will showcase new findings from Phase 3 trials in patients with narcolepsy, outlining data on symptom severity and functional impairment. Researchers, including Dr. Richard Bogan and Dr. Michael Thorpy, will share insights into how AXS-12 may promote wakefulness and improve patient outcomes. Additionally, two sessions will present real-world data on solriamfetol, discussing its impact on neuropsychological outcomes and its effectiveness in managing excessive daytime sleepiness in individuals with obstructive sleep apnea. These sessions highlight promising advancements in treatment options for sleep disorders.
Read Announcement- Drug:
- AXS-12
- Announced Date:
- November 26, 2024
- Indication:
- Narcolepsy
Announcement
Axsome Therapeutics, Inc. announced that AXS-12 (reboxetine), a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator, achieved the primary endpoint in the ENCORE Phase 3 trial, demonstrating a statistically significant improvement in the frequency of cataplexy attacks compared to placebo.
AI Summary
Axsome Therapeutics announced positive results from its ENCORE Phase 3 trial, where AXS-12 (reboxetine) significantly reduced the frequency of cataplexy attacks compared to placebo (p=0.017). In the trial’s double-blind phase, patients switching to placebo experienced a clear increase in weekly cataplexy episodes, while those who continued AXS-12 maintained low attack rates. This demonstrates the drug’s meaningful impact on one of narcolepsy’s most challenging symptoms.
AXS-12 is a highly selective norepinephrine reuptake inhibitor and cortical dopamine modulator. Besides reducing cataplexy, the trial also showed improvements in cognition, overall narcolepsy symptoms, and excessive daytime sleepiness. The treatment was well tolerated over the long term, with a safety profile consistent with previous studies. These results present AXS-12 as a promising new option for managing narcolepsy symptoms and improving patient quality of life.
Read Announcement- Drug:
- AXS-12
- Announced Date:
- September 24, 2024
- Indication:
- Narcolepsy
Announcement
Axsome Therapeutics, Inc. announced seven presentations on AXS-12 and solriamfetol at Sleep Europe 2024, the 27th Congress of the European Sleep Research Society, being held September 24-27, 2024, in Seville, Spain.
AI Summary
Axsome Therapeutics, Inc. announced that it will deliver seven presentations at Sleep Europe 2024, the 27th Congress of the European Sleep Research Society, held from September 24-27, 2024, in Seville, Spain. The presentations will focus on the company’s investigational treatments AXS-12 and solriamfetol. Key sessions include the topline results from the Phase 3 SYMPHONY trial of AXS-12 for narcolepsy and data from the CRESCENDO patient survey that underscores important unmet needs in patients with type 1 narcolepsy. Additional presentations on solriamfetol will cover its impact on cognitive function, maintenance of wakefulness in patients with narcolepsy and obstructive sleep apnea (OSA), and its real-world use in patients with excessive daytime sleepiness. These sessions, led by leading experts in the field, aim to provide the latest scientific insights into novel treatment options for central nervous system disorders.
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AXS-14 (esreboxetine) - FDA Regulatory Timeline and Events
AXS-14 (esreboxetine) is a drug developed by Axsome Therapeutics for the following indication: Fibromyalgia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AXS-14 (esreboxetine)
- Announced Date:
- June 9, 2025
- Indication:
- Fibromyalgia
Announcement
Axsome Therapeutics, Inc. announced it has received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for AXS-14 (esreboxetine) for the management of fibromyalgia.
AI Summary
Axsome Therapeutics has received a Refusal to File (RTF) letter from the FDA regarding its New Drug Application for AXS-14 (esreboxetine), a potential treatment for fibromyalgia. The FDA’s initial review concluded that the NDA was not complete enough for a full review. In particular, the agency raised concerns about one of the two placebo-controlled trials submitted. That trial, which used a flexible-dose design and an 8-week primary endpoint, was deemed inadequate. However, the FDA found that the first trial—conducted with a fixed-dose design and a 12-week endpoint—was adequate and well-controlled. In response, Axsome plans to meet the FDA’s feedback by initiating a new controlled trial with a fixed-dose regimen and a 12-week primary endpoint, with plans to start this trial in the fourth quarter of 2025.
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solriamfetol - FDA Regulatory Timeline and Events
solriamfetol is a drug developed by Axsome Therapeutics for the following indication: Treatment for attention deficit hyperactivity disorder (ADHD) in adults.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- solriamfetol
- Announced Date:
- May 27, 2025
- Indication:
- Treatment for attention deficit hyperactivity disorder (ADHD) in adults.
Announcement
Axsome Therapeutics, Inc. nnounced that it has entered into a settlement agreement with Hetero Labs Ltd. and certain of its affiliates (Hetero) resolving patent litigation related to Axsome's product SUNOSI® (solriamfetol).
AI Summary
Axsome Therapeutics, Inc. has reached a settlement with Hetero Labs Ltd. and its affiliates to resolve patent litigation concerning its product SUNOSI® (solriamfetol). The dispute began when Hetero submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to market a generic version of SUNOSI in the United States.
Under the agreement, Axsome will grant Hetero a license to sell its generic version of SUNOSI starting either on March 1, 2040—if pediatric exclusivity is not granted—or on September 1, 2040—if pediatric exclusivity is awarded. All sales are subject to FDA approval and standard conditions. Both parties will also submit the settlement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
Read Announcement- Drug:
- solriamfetol
- Announced Date:
- April 1, 2025
- Indication:
- Treatment for attention deficit hyperactivity disorder (ADHD) in adults.
Announcement
Axsome Therapeutics, Inc. announced results of the PARADIGM Phase 3 proof-of-concept trial of solriamfetol in major depressive disorder (MDD) with and without severe excessive daytime sleepiness (EDS).
AI Summary
Axsome Therapeutics recently announced results from its PARADIGM Phase 3 proof-of-concept trial evaluating solriamfetol in patients with major depressive disorder (MDD) who experience severe excessive daytime sleepiness (EDS) as well as those without EDS. Although the overall trial did not meet its primary endpoint on the Montgomery-Åsberg Depression Rating Scale compared to placebo, the subgroup of MDD patients with severe EDS showed more improvement in depressive symptoms when treated with solriamfetol.
These encouraging findings in the severe EDS subgroup support further research, and Axsome plans to launch a Phase 3 trial focusing on MDD patients with EDS in 2025. The study highlights the high unmet need in MDD patients who experience EDS, a condition which affects about 50 percent of individuals with MDD and significantly impacts their daily lives.
Read Announcement- Drug:
- solriamfetol
- Announced Date:
- March 25, 2025
- Indication:
- Treatment for attention deficit hyperactivity disorder (ADHD) in adults.
Announcement
Axsome Therapeutics, Inc. announced that the FOCUS Phase 3 trial of solriamfetol in the treatment of attention deficit hyperactivity disorder (ADHD) achieved its primary and key secondary endpoints demonstrating statistically significant improvements in ADHD symptoms and disease severity with solriamfetol compared to placebo.
AI Summary
Axsome Therapeutics announced positive results from the FOCUS Phase 3 trial evaluating solriamfetol for adult ADHD. In the study, 516 adults were treated daily for 6 weeks with either 150 mg or 300 mg of solriamfetol, or with placebo. The trial met its primary endpoint by showing a statistically significant reduction in ADHD symptoms, measured by the Adult ADHD Investigator Symptom Rating Scale (AISRS), with a p-value of 0.039 for the 150 mg dose.
The study also met its key secondary endpoint by demonstrating a significant reduction in overall ADHD severity, as assessed by the Clinical Global Impression of Severity (CGI-S) with a p-value of 0.017. Symptom improvement was observed as early as Week 1, and a higher rate of clinical response was noted compared to placebo. Solriamfetol was well tolerated, suggesting it may be a promising new treatment option for adults with ADHD.
Read Announcement- Drug:
- solriamfetol
- Announced Date:
- August 21, 2024
- Indication:
- Treatment for attention deficit hyperactivity disorder (ADHD) in adults.
Announcement
Axsome Therapeutics, Inc. announced that it has reached agreement with Sandoz Inc. (Sandoz) to dismiss the patent litigation related to Axsome's product Sunosi® (solriamfetol).
AI Summary
Axsome Therapeutics, Inc. announced that it has reached an agreement with Sandoz Inc. to dismiss the patent litigation related to its product Sunosi® (solriamfetol). The lawsuit began when Sandoz submitted an Abbreviated New Drug Application (ANDA) to the US FDA, seeking to market a generic equivalent of Sunosi. Sandoz has since withdrawn its ANDA request, which led to the dismissal of the case without prejudice in the United States District Court for the District of New Jersey.
This resolution ends the current legal challenge and allows Axsome to continue focusing on its work in developing new treatments for central nervous system disorders. By resolving the dispute over Sunosi, the company can now concentrate its resources on advancing its innovative therapies to improve patient outcomes and expand treatment options for conditions with limited alternatives.
Read Announcement- Drug:
- solriamfetol
- Announced Date:
- June 5, 2024
- Indication:
- Treatment for attention deficit hyperactivity disorder (ADHD) in adults.
Announcement
Axsome Therapeutics, Inc. announced that it has entered into a settlement agreement with Unichem Laboratories Ltd. (Unichem) resolving patent litigation related to Axsome's product Sunosi® (solriamfetol).
AI Summary
Axsome Therapeutics, Inc. has reached a settlement with Unichem Laboratories Ltd., ending a patent dispute over its product Sunosi® (solriamfetol). The litigation took place in the U.S. District Court for the District of New Jersey after Unichem filed an Abbreviated New Drug Application to market a generic version of Sunosi. Under the settlement agreement, Unichem will be allowed to sell its generic version starting on June 30, 2042, unless earlier conditions are met. This agreement also considers potential extensions related to pediatric exclusivity. In compliance with legal requirements, both companies will submit the settlement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. The resolution of this litigation helps clarify the market pathway for generic competition for Sunosi while Axsome continues to work on its other legal matters in related patent disputes.
Read Announcement- Drug:
- solriamfetol
- Announced Date:
- May 29, 2024
- Indication:
- Treatment for attention deficit hyperactivity disorder (ADHD) in adults.
Announcement
Axsome Therapeutics, Inc. announced five presentations, including two featured oral plenary presentations, on solriamfetol at SLEEP 2024, the 38th annual meeting of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS), being held June 1-5, 2024, in Houston, Texas.
AI Summary
Axsome Therapeutics is set to showcase its latest research on solriamfetol at SLEEP 2024, the 38th annual meeting of the American Academy of Sleep Medicine and the Sleep Research Society. The company announced five presentations during the conference, including two featured oral plenary sessions. One plenary presentation, led by Professor Hans Van Dongen from Washington State University, will focus on the SHARP study, which demonstrated improvements in cognitive functioning—such as executive function, memory, and processing speed—in patients with obstructive sleep apnea who also experience excessive daytime sleepiness. Another plenary session, presented by Dr. Yaroslav Winter, will discuss the effects of solriamfetol on patients with narcolepsy-related sleepiness. The sessions will be held in Houston, Texas, from June 1-5, 2024, highlighting advances in the treatment of sleep disorders.
Read Announcement
SYMBRAVO - FDA Regulatory Timeline and Events
SYMBRAVO is a drug developed by Axsome Therapeutics for the following indication: For the Acute Treatment of Migraine.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SYMBRAVO
- Announced Date:
- June 18, 2025
- Indication:
- For the Acute Treatment of Migraine
Announcement
Axsome Therapeutics, Inc. announced that data from across the SYMBRAVO® (meloxicam and rizatriptan) clinical program will be presented at the 67th Annual Scientific Meeting of the American Headache Society (AHS), being held June 19-22, 2025, in Minneapolis, Minnesota.
AI Summary
Axsome Therapeutics, Inc. announced that it will present data from its SYMBRAVO® clinical program at the 67th Annual Scientific Meeting of the American Headache Society, held in Minneapolis, Minnesota from June 19-22, 2025. The clinical program evaluates SYMBRAVO®—an oral, single-dose treatment for acute migraine that combines meloxicam and rizatriptan.
The presentations cover multiple trials, including a post-hoc analysis of the INTERCEPT trial focusing on baseline migraine-associated disability, long-term effects on headache burden and quality of life in the MOVEMENT trial, and topline results from the EMERGE trial, which studied patients who did not respond adequately to oral CGRP inhibitors. These studies underscore the potential of SYMBRAVO® to provide rapid, consistent relief and to address a significant unmet need in migraine treatment.
Read Announcement- Drug:
- SYMBRAVO
- Announced Date:
- June 10, 2025
- Indication:
- For the Acute Treatment of Migraine
Announcement
Axsome Therapeutics, Inc. announced that SYMBRAVO® (meloxicam and rizatriptan) is now available by prescription in the United States for the acute treatment of migraine with or without aura in adults.1 SYMBRAVO represents a novel multi-mechanistic approach to treating migraine that targets multiple brain pathways underlying a migraine attack.
AI Summary
Axsome Therapeutics recently announced that SYMBRAVO® (meloxicam and rizatriptan) is now available by prescription in the United States for the acute treatment of migraine with or without aura in adults. This new medication represents a novel, multi-mechanistic approach that targets several brain pathways involved in a migraine attack. It is designed to provide rapid migraine pain relief, with some patients experiencing pain freedom as early as two hours after taking a single dose.
SYMBRAVO also comes with comprehensive patient support through the SYMBRAVO On My Side program, which helps with access, prescription drug support, and educational resources. This approval offers a promising new option for individuals who have not found enough relief with existing treatments, potentially addressing an unmet need for millions of migraine sufferers.
Read Announcement- Drug:
- SYMBRAVO
- Announced Date:
- January 30, 2025
- Indication:
- For the Acute Treatment of Migraine
Announcement
Axsome Therapeutics, Inc announced that the U.S. Food and Drug Administration (FDA) has approved SYMBRAVO® (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults.1 SYMBRAVO represents a novel multi-mechanistic approach to treating migraine that targets multiple pathways underlying a migraine attack.
AI Summary
Axsome Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved SYMBRAVO® (a combination of meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults. This new treatment option uses a novel multi-mechanistic approach to target multiple pathways behind a migraine attack. By combining a COX-2 preferential non-steroidal anti-inflammatory drug (meloxicam) with a 5-HT1B/1D agonist (rizatriptan), SYMBRAVO aims to quickly stop migraine pain. With its rapid absorption technology, the drug has been shown to provide fast relief, allowing patients to return to normal activities after a single dose. The approval marks an important advancement for adults seeking an effective and innovative solution to manage migraine attacks.
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