NEW YORK, June 18, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today 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.
Details for the presentations are as follows:
Title: Efficacy of SYMBRAVO® (MoSEIC™ meloxicam and rizatriptan) by Baseline Migraine-Associated Disability: Post-Hoc Analysis of the INTERCEPT Trial Lead Author: Stewart Tepper, MD, Clinical Professor of Neurology at the Geisel School of Medicine at Dartmouth and Vice President of the New England Institute for Neurology and Headache Presentation Date and Time: Thursday, June 19, 6 - 7:30 p.m. Central Time Poster Number: P-316
Title: Long-Term Effects of SYMBRAVO® (MoSEIC™ meloxicam and rizatriptan) on Headache Burden and Quality of Life: Results of the MOVEMENT Trial Lead Author: Richard B. Lipton, MD, Professor of Neurology and Director of the Montefiore Headache Center, Albert Einstein College of Medicine Presentation Date and Time: Thursday, June 19, 6 - 7:30 p.m. Central Time Poster Number: P-330
Title: Efficacy and Safety of SYMBRAVO® (MoSEIC™ meloxicam and rizatriptan) in Participants with Migraine Experiencing an Inadequate Response to Oral CGRP Inhibitors: Topline Results from the EMERGE Trial Lead Author: Richard B. Lipton, MD, Professor of Neurology and Director of the Montefiore Headache Center, Albert Einstein College of Medicine Presentation Date and Time: Saturday, June 21, 8:50 - 9 a.m. Central Time Session: Industry Abstracts IOR-03
About SYMBRAVO
SYMBRAVO (meloxicam and rizatriptan; 20 mg/10 mg tablets) is a novel, oral, single-dose medicine approved for the acute treatment of migraine with or without aura in adults. SYMBRAVO consists of MoSEIC™ meloxicam and rizatriptan. Meloxicam is a new molecular entity for migraine enabled by Axsome’s MoSEIC (Molecular Solubility Enhanced Inclusion Complex) technology, which enables the rapid absorption of meloxicam while maintaining a long plasma half-life. Meloxicam is a COX-2 preferential non-steroidal anti-inflammatory drug (NSAID) and rizatriptan is a 5-HT1B/1D agonist. SYMBRAVO is designed to provide rapid, enhanced, and consistent migraine pain relief, and reduced symptom recurrence. The exact mechanism of action of SYMBRAVO in the treatment of acute migraine is unknown.
For more information, visit www.symbravo.com.
INDICATION AND IMPORTANT SAFETY INFORMATION
What is SYMBRAVO (sim-BRAH-voh)? SYMBRAVO is a combination of meloxicam (an NSAID) and rizatriptan (a triptan). SYMBRAVO is an oral prescription medicine used to treat acute migraine headaches with or without aura in adults.
SYMBRAVO is not used to prevent or decrease the number of migraine headaches you have or for treatment of hemiplegic or basilar migraines. SYMBRAVO is not indicated as a treatment for cluster headaches or for use in children.
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT SYMBRAVO?
SYMBRAVO may increase the risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase with increasing doses, and longer use, of NSAIDs.
Do not take SYMBRAVO right before or after a heart surgery called a “coronary artery bypass graft” (CABG).
Avoid taking SYMBRAVO after a recent heart attack unless your healthcare provider (HCP) tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.
Stop taking SYMBRAVO and get emergency help right away if you have any of the following symptoms which can be indicative of a heart attack or stroke:
discomfort in your chest that lasts for more than a few minutes, or that goes away and comes back severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw pain or discomfort in your arms, back, neck, jaw, or stomach shortness of breath with or without chest discomfort
breaking out in a cold sweat nausea or vomiting feeling lightheaded weakness in one part or one side of your body slurred speech
People with risk factors for heart disease should not take SYMBRAVO unless a heart exam is done and shows no problem. You have higher risk for heart disease if you:
have high blood pressure have high cholesterol smoke
are overweight have diabetes or a family history of diabetes
SYMBRAVO can increase the risk of potentially life-threatening bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach, and intestines that can occur anytime during use and without warning symptoms.
SYMBRAVO may cause serious allergic or skin reactions which can be life-threatening. Stop taking SYMBRAVO and get emergency help right away if you develop:
sudden wheezing or problems breathing or swallowing rash or reddening of your skin with blisters or peeling
blisters or bleeding of your lips, eye lids, mouth, nose, or genitals swelling of your lips, tongue, throat or body fainting
SYMBRAVO already contains an NSAID (meloxicam). Do not use SYMBRAVO with other medicines to lessen pain or fever or with other medicines for colds or sleeping problems without talking to your HCP first, because they may contain an NSAID also.
Do not take SYMBRAVO if you:
have or had heart problems or right before or after heart bypass surgery have or had a stroke or transient ischemic attack (TIA) take propranolol containing medicines have taken other triptan or ergot- containing medicines within the last 24 hours take an antidepressant medicine called monoamine oxidase inhibitor (MAOI) or have taken a MAOI within the last 2 weeks
have or had blood vessel problems of your legs and arms, stomach (ischemic bowel disease), or kidneys have or had hemiplegic or basilar migraines have uncontrolled high blood pressure are allergic to meloxicam, rizatriptan, NSAIDs, or any of the ingredients in SYMBRAVO have had an asthma attack, hives, or other allergic reaction after taking aspirin or any other NSAIDs have moderate to severe kidney problems and are at risk of kidney failure or if you are on dialysis
SYMBRAVO may cause serious side effects. These serious side effects include:
heartbeats that are too fast or too slow (arrhythmias) new or worse high blood pressure heart failure life-threatening skin reactions
liver or kidney problems including organ failure low red blood cell count (anemia) asthma attacks in people who have asthma
Medication Overuse Headaches: Some people who use too many SYMBRAVO tablets may have worse headaches. If your headaches get worse, your HCP may decide to stop your treatment with SYMBRAVO.
Stop taking SYMBRAVO and get emergency help right away if you have any of the following:
Stop taking SYMBRAVO and call your healthcare provider right away if you have any of the following symptoms:
nausea vomiting blood more tired or weaker than usual blood in your bowel movement or it is black and sticky like tar diarrhea itching, skin rash, or blisters with fever unusual weight gain your skin or eyes look yellow
indigestion or stomach pain swelling of the arms, legs, hands, or feet flu-like symptoms tenderness in your right upper side vision problems
COMMON SIDE EFFECTS
The most common side effects of SYMBRAVO include dizziness and tiredness.
These are not all the possible side effects of SYMBRAVO. Tell your doctor if you have any side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1–800-FDA-1088.
BEFORE USING
Tell your HCP about all your medical conditions, including if you:
Review the list below with your HCP. SYMBRAVO may not be right for you if:
HOW TO TAKE
LEARN MORE
For more information about SYMBRAVO, call 866-496-2976 or visit SYMBRAVO.com.
This summary provides basic information about SYMBRAVO but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other HCP about SYMBRAVO and how to take it. Your HCP is the best person to help you decide if SYMBRAVO is right for you.
SYM CON BS 01/2025
Please see full Prescribing Information, including Boxed Warning for risk of serious cardiovascular and gastrointestinal adverse events, and Medication Guide.
About Axsome Therapeutics
Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.
Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
Investors: Mark Jacobson Chief Operating Officer (212) 332-3243 mjacobson@axsome.com
Media: Darren Opland Director, Corporate Communications (929) 837-1065 dopland@axsome.com
Source: Axsome Therapeutics, Inc.
