FDA Clears NSAID/Triptan Combo for Migraine in Adults
The US Food and Drug Administration (FDA) has approved a novel formulation combining rizatriptan and the nonsteroidal anti-inflammatory drug meloxicam (Symbravo, Axome Therapeutics) for the acute treatment of migraine with or without aura in adults.
“Symbravo incorporates Axsome’s rapid absorption technology and mechanisms that target multiple migraine attack pathways,” the company explained in a news release announcing approval.
The company expects Symbravo to be available in about 4 months.
The approval is based on the results of the phase 3 MOMENTUM trial, which enrolled adults with migraine of moderate and severe pain intensity; the phase 3 INTERCEPT trial, which treated early-onset migraine when the initial pain was mild; and the phase 3 MOVEMENT long-term open label safety trial.
Altogether, more than 21,000 migraine attacks were treated with the rizatriptan/meloxicam combination.
According to the company, a single oral dose of the combination provided “rapid migraine pain freedom and return to normal functioning within 2 hours, and sustained efficacy through 24 and 48 hours,” with most patients not needing migraine rescue medication within 24 hours.
“A significant proportion of migraine patients experience inadequate efficacy with currently available acute treatments, leading to even greater suffering, and an increased risk of worsening of migraine pain and attack frequency,” Richard B. Lipton, MD, director of the Montefiore Headache Center, Albert Einstein College of Medicine, the Bronx, NY, commented in the news release.
“Results of multiple clinical trials demonstrate that Symbravo can provide rapid and long-lasting freedom from migraine pain, whether treatment is taken early in the attack while the pain is mild, or later in the attack when the pain may be severe. The approval of Symbravo is a long awaited and much welcomed advancement for clinicians and our patients, providing a new, meaningful treatment option,” said Lipton.
The drug is not intended to prevent or decrease the number of migraine headaches, or to treat hemiplegic or basilar migraine or cluster headache. It is not approved for use in children.
Full prescribing information and medication guide are available online.
According to the American Migraine Foundation, more than 39 million Americans suffer from migraine, which is the leading cause of disability among neurological disorders in the United States.
