United States: The US Food and Drug Administration authorized Symbravo (meloxicam and rizatriptan) to treat migraine attacks in adults, either with or without aura symptoms.
More about the news
An approval decision was made through the evaluation of three phase 3 clinical trials, which totaled more than 21,000 migraine attacks.
The MOMENTUM trial demonstrated that Symbravo outperformed placebo in delivering pain freedom and reducing most bothersome symptoms such as photophobia, phonophobia, or nausea by obtaining statistically greater patient response rates at the two-hour time point that lasted through 24 and 48 hours for numerous patients.
Details of trial
During the INTERCEPT trial, scientists applied Symbravo to treat mild-level migraine pain, and the results matched the other trials.
The long-term safety profile of Symbravo was demonstrated in the MOVEMENT trial involving 706 patients who were administered the treatment for at least two migraines monthly.
Somnolence and dizziness emerged as the leading adverse events reported by these patients.
What more are the experts stating?
According to Herriot Tabuteau, M.D., CEO of Axsome Therapeutics, “Migraine attacks strike without warning, and disrupt the lives of estimated more than 39 million patients in the U.S. alone,” US News reported.
“Symbravo provides patients and clinicians an important new option which can quickly stop a migraine attack, keep it away, and allow patients to resume their normal activities, with just a single dose.”
The Food and Drug Administration approved Symbravo for general use under Axsome Therapeutics.