Axsome Therapeutics Receives FDA Approval for SYMBRAVO® to Treat Acute Migraine in Adults
Friday, January 31, 2025
Axsome Therapeutics, Inc. a biopharmaceutical company focused on central nervous system (CNS) disorders, has received approval from the U.S. Food and Drug Administration (FDA) for SYMBRAVO® (meloxicam and rizatriptan). The treatment is intended for acute migraine relief in adults, with or without aura.
SYMBRAVO is designed to target multiple pathways involved in migraine attacks, offering a new approach to treatment. It can provide rapid pain relief and restore normal function, with some patients experiencing sustained benefits for up to 24 or 48 hours after a single dose. Clinical trials have shown its effectiveness in different scenarios, including when taken at the earliest stage of a migraine, during moderate or severe pain, and in patients with varied responses to previous treatments. Axsome Therapeutics expects SYMBRAVO to be available in the U.S. within four months.
The FDA approval is based on results from three Phase 3 clinical trials: MOMENTUM, INTERCEPT, and MOVEMENT. These studies assessed SYMBRAVO’s safety and effectiveness in treating migraines of varying intensity. The MOMENTUM trial demonstrated that SYMBRAVO was significantly more effective than a placebo in achieving pain relief, reducing symptoms such as sensitivity to light and sound, and enabling patients to resume normal activities. In a direct comparison, SYMBRAVO also showed superior sustained pain relief compared to rizatriptan. The INTERCEPT trial confirmed similar benefits when SYMBRAVO was taken early in a migraine attack.
Across both trials, many patients did not need additional rescue medication within 24 hours of taking SYMBRAVO. Common side effects observed in clinical studies included drowsiness and dizziness, reported in 2% and 1% of patients, respectively. The long-term safety of SYMBRAVO was evaluated in the MOVEMENT trial, which followed patients for up to 12 months.
SYMBRAVO incorporates Axsome’s MoSEICTM rapid absorption technology, allowing faster absorption of meloxicam while maintaining a long-lasting effect. This innovation supports its use as a new treatment for acute migraine relief. The product is covered by patents extending until at least 2040.
Migraine is a widespread and often debilitating condition that affects millions of people. The introduction of SYMBRAVO provides a new treatment option designed to meet the needs of patients seeking effective and long-lasting migraine relief.
Source: gcs-web.com
