Eli Lilly announced the launch of Reyvow (lasmiditan) for the acute treatment of migraine with or without aura in adult patients.
Reyvow is a first-in-class, serotonin (5-HT) 1F receptor agonist that is believed to exert its therapeutic effects both centrally and peripherally. Following review by the Drug Enforcement Administration (DEA), the product has been classified as a Schedule V controlled substance. “This is consistent with our data that shows that Reyvow has a low abuse potential and no evidence of withdrawal,”said Gudarz Davar, MD, vice president, neurology development, Lilly Bio-Medicines.
The approval was based on data from two phase 3 trials, SAMURAI and SPARTAN, that included 4439 patients who took 50mg, 100mg, or 200mg doses of Reyvow or placebo. Results across both studies showed that a significantly greater percentage of patients treated with Reyvow were migraine pain-free 2 hours following the first dose vs those who received placebo. In addition, compared with placebo, more patients in the lasmiditan group were found to be free of their most bothersome symptom at 2 hours following the first dose.
With regard to safety, the most common adverse reactions include dizziness, fatigue, paresthesia, sedation, nausea and/or vomiting, and muscle weakness. As the drug causes CNS depression, patients are advised not to drive or operate machinery for at least 8 hours after taking Reyvow; prescribers should be aware that patients may not be able to assess their own driving competence and the degree of impairment caused by the drug.
“Recent guidance issued by both the FDA and the American Headache Society raised the clinical bar by recommending migraine clinical trial efficacy demonstrates pain freedom and freedom from most bothersome symptoms, rather than just pain relief,” said Dr Cori Millen, medical director of Summit Headache and Neurologic Institute. “Reyvow is the first FDA-approved acute medicine for migraine to meet this new standard.”
Additionally, the Company offers a copay savings card to assist patients. The product is supplied in 50mg and 100mg tablet strengths in cartons containing 8 tablets.
For more information visit reyvow.com.
This article originally appeared on MPR