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Currently under DEA review.
The FDA granted approval to oral lasmiditan (Reyvow , Eli Lilly & Co.) to treat migraine, with or without aura, in adults.
Lasmiditan has a unique mechanism of action and is the first and only FDA-approved medicine in a new class of acute treatment for migraine (serotonin 5-HT1F receptor agonists), says Eli Lilly in a statement. According to lasmiditan’s prescribing information, the therapeutic affect is presumed to be a result of agonist effects at the 5-HT1F receptor.
The New Drug Application for lasmiditan included data from two Phase 3 single-attack studies. Both studies met the efficacy endpoints of pain freedom and freedom from most bothersome symptom (MBS; patient selected from nausea, sensitivity to light, or sensitivity to sound) at two hours following administration of lasmiditan in comparison to placebo.
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The recommended controlled substance classification for Reyvow is currently under review by the DEA and is expected within 90 days of the FDA’s approval, after which Reyvow will be available to patients in retail pharmacies,” Eli Lilly says.
“Considering up to 40% of people with migraine do not get adequate responses from their initial acute treatment prescription, having a new and novel option like Reyvow is an important development for physicians and the patients we treat,” says Jan Brandes, MD, assistant clinical professor in the Department of Neurology at Vanderbilt University, in the Eli Lilly statement.
As with other medicines with central nervous system (CNS) activity, the FDA required abuse potential studies for lasmiditan. Consistent with the FDA's guidance, Lilly conducted a human abuse potential assessment; as part of that assessment, therapeutic doses of lasmiditan were associated with less drug liking when compared to alprazolam (Xanax), but more than placebo.
There is a risk of driving impairment while taking lasmiditan, so patients are advised not to drive or operate machinery for at least eight hours after taking lasmiditan, even if they feel well enough to do so, FDA says. “Patients who cannot follow this advice are advised not to take Reyvow,” the agency says.
The drug also causes CNS depression, including dizziness and sedation. “It should be used with caution if taken in combination with alcohol or other CNS depressants,” FDA says.
The most common adverse reactiosn reported with the use of lasmiditan include diziiness, fatigue, paresthesia, and sedation.
Lasmiditan is not indicated for the preventive treatment of migraine.