The FDA has approved Eli Lilly’s Reyvow (lasmiditan), the first and only medicine in a new class of acute treatment for migraine.
As with other medicines with central nervous system (CNS) activity, the FDA required abuse potential studies for Reyvow.
Consistent with the FDA’s guidance, Lilly conducted a human abuse potential assessment; as part of that assessment, therapeutic doses of Reyvow were associated with less drug liking when compared to alprazolam, but more than placebo.
The recommended controlled substance classification for Reyvow is currently under review by the Drug Enforcement Administration (DEA) and is expected within 90 days of FDA approval, after which Reyvow will be available to patients in retail pharmacies.
The New Drug Application (NDA) for Reyvow included data from two Phase 3 single-attack studies (SAMURAI and SPARTAN), which evaluated the safety and efficacy of Reyvow for the acute treatment of migraine in adults.
Both studies met the efficacy endpoints of pain freedom and freedom from most bothersome symptom at two hours following administration of Reyvow in comparison to placebo.