FDA Approves Symbravo, a Combination NSAID/Triptan Therapy for Migraine Relief
New Option for Migraine Sufferers
The FDA has approved Symbravo, a novel combination of rizatriptan (a triptan) and meloxicam (a nonsteroidal anti-inflammatory drug), developed by Axsome Therapeutics, for the acute treatment of migraine with or without aura in adults. This approval offers a new hope for patients who experience inadequate relief from currently available migraine medications.
What Makes Symbravo Different?
Symbravo utilizes Axsome’s rapid absorption technology, designed to target multiple migraine pathways. This allows for faster relief and extended pain control. Clinical trials show that a single dose can provide:
Rapid pain relief within two hours
Sustained relief for up to 48 hours
Reduced need for rescue medication within 24 hours
The Clinical Trials Behind the Approval
The approval is based on data from three Phase 3 clinical trials:
MOMENTUM Trial: Focused on moderate to severe migraines
INTERCEPT Trial: Studied treatment during early onset of mild pain
MOVEMENT Trial: A long-term safety study
Collectively, these trials treated over 21,000 migraine attacks, providing substantial evidence of Symbravo’s efficacy and safety.
Expert Insights
According to Dr. Richard B. Lipton, Director of the Montefiore Headache Center, many migraine patients struggle with inadequate treatment options. He notes that Symbravo offers a much-needed advancement by providing fast and long-lasting pain relief, regardless of whether the medication is taken early or later in an attack.
Who Can Use Symbravo?
While promising, Symbravo is not for everyone. It is not approved for:
Preventing migraines or reducing their frequency
Treating hemiplegic or basilar migraines
Treating cluster headaches
Use in children
Availability and Next Steps
Symbravo is expected to be available in about four months. Full prescribing information, including potential side effects and contraindications, can be found online.
With over 39 million Americans affected by migraines, this FDA approval brings renewed hope to millions seeking better and faster relief.