Eli Lilly announced that lasmiditan (Reyvow) C-V 50 mg and 100 mg tablets, its oral medication for the acute treatment of migraine with or without aura in adults, is now available for prescription.
Lasmiditan is the first FDA-approved ditan, a 5-HT1F receptor agonist, which works differently than other acute treatments of migraine. Representing a new class of migraine medications, 5-HT1F receptor agonists are believed to act both centrally and peripherally.
The efficacy of lasmiditan is based on data from the SAMURAI and SPARTAN clinical trials including 4439 patients. In the study, patients took 50-mg, 100-mg, or 200-mg doses of lasmiditan or placebo.
According to the results, 28-39% of patients achieved complete elimination of migraine pain at 2 hours with lasmiditan compared with 15% and 21% with placebo, across 2 clinical trials and 3 doses. Additionally, 41-49% of patients achieved freedom from their most bothersome symptom at 2 hours with lasmiditan versus 30% and 33% with placebo.
Treatment-emergent adverse events (AEs) reported in the study were generally mild to moderate. Most frequently-reported AEs included dizziness, fatigue, paresthesia, sedation, nausea and/or vomiting, and muscle weakness.
Moreover, Lilly conducted 2 driving studies to assess the impact of lasmiditan on study participants’ ability to drive. According to the study results, lasmiditan was shown to potentially cause significant driving impairment, as all doses of the drug affected participants’ ability to drive. More sleepiness was also reported at 8 hours compared with placebo. Other warnings and precautions include CNS depression, serotonin syndrome, and medication overuse headache.
“As a health care professional, I am thrilled that Reyvow is now available. In only 2 hours and with a single dose, Reyvow has demonstrated the chance for patients to achieve rapid and complete elimination of migraine pain and their most bothersome symptom of sensitivity of light, sensitivity to sound, or nausea,” Dr Cori Millen, medical director of Summit Headache and Neurologic Institute, said in a statement. “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. Reyvow is the first FDA-approved acute medicine for migraine to meet this new standard.”
Lasmiditan is available in 50 mg, 100 mg, and 200 mg doses for patients, which offers dosing flexibility for physicians and other prescribers, according to Lilly. Lasmiditan is not indicated for the preventive treatment of migraine.
- Lilly’s Reyvow (lasmiditan) C-V, the First and Only Medicine in a New Class of Acute Treatment for Migraine (ditan), Now Available for Prescription [news release]. Eli Lilly’s website. https://investor.lilly.com/news-releases/news-release-details/lillys-reyvowtm-lasmiditan-c-v-first-and-only-medicine-new-class. Accessed February 3, 2020.