The drug will be available in 50 mg and 100 mg oral tablets in pharmacies across the US in the coming days.
Cori Millen, MD
Eli Lilly has announced that lasmiditan (Reyvow), an oral medication approved for the acute treatment of migraine with or without aura, is now available for prescription and will be available in pharmacies in the US in the next few days.
Lasmiditan, which is the first molecule in the ditan drug class to be approved, is a non-opioid/non-narcotic, Schedule V medication that can be prescribed to patients in 50 mg, 100 mg, and 200 mg doses. The product will be available in 50 mg and 100 mg tablets.
"As a healthcare 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 to light, sensitivity to sound, or nausea," said Cori Millen, MD, medical director of Summit Headache and Neurologic Institute, in a statement.1
In October 2019, the FDA approved lasmiditan for the acute treatment of migraine with or without aura in adults.2
The approval was based off results from the SAMURAI and SPARTAN phase 3 trials, in which lasmiditan demonstrated a high rate of pain-freedom in patients with migraine, as well as relief from the most bothersome symptom (MBS).3
Both trials included a total of 4439 patients who received either 50 mg, 100 mg, or 200 mg of lasmiditan or placebo. Results from the randomized, double-blind, placebo-controlled trials showed that 28% to 39% of patients achieved complete elimination of migraine pain at 2 hours with lasmiditan compared to 15% and 21% with placebo.
The oral, centrally-penetrant, selective serotonin 5-HT1F antagonist showed significant results in reducing MBS, with 41-49% of patients achieved freedom from their MBS at 2 hours with lasmiditan compared to just 30% and 33% with placebo.
The most frequent treatment-emergent adverse events (TEAEs) included dizziness, fatigue, paresthesia, sedation, nausea and/or vomiting, and muscle weakness. Investigators noted that these events were generally mild to moderate.
Notably, patients reported significant driving impairment and increased sleepiness after administration of lasmiditan compared with placebo. Central nervous system reactions such as depression, dizziness, and sedation may result from patients taking lasmiditan. Patients should not drive or operate machinery for at least 8 hours after taking lasmiditan.
Reactions consistent with serotonin syndrome may occur with lasmiditan during coadministration with serotonergic drugs, including selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, tricyclic antidepressants, and monoamine oxidase inhibitors. Other serotonin syndrome symptoms include mental status changes, neuromuscular signs, and/or gastrointestinal signs and symptoms.
Investigators evaluated the human abuse potential of lasmiditan in a subset study of 58 recreational, poly-drug users who received single oral therapeutic doses (100 mg and 200 mg) and a supratherapeutic dose of 400 mg, compared to alprazolam 2 mg and placebo. Investigators noted that lasmiditan does have abuse potential, demonstrated by the statistically higher “drug liking” scores than placebo, however these adverse events, including euphoria and hallucinations, occur at a low frequency.
"With a single dose, Reyvow offers the chance for quick and complete elimination of moderate to severe migraine pain in just two hours. When asking people with migraine, they prioritize fast and complete elimination of pain from acute treatments. We feel fortunate we can now provide patients with a treatment option that helps achieve that outcome," Michael Cobas Meyer, MD, vice president, global medical affairs, Lilly Bio-Medicines, said in a statement.1
1. 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]. Indianapolis, ID. Eli Lilly. January 31, 2020. prnewswire.com/news-releases/lillys-reyvow-lasmiditan-c-v-the-first-and-only-medicine-in-a-new-class-of-acute-treatment-for-migraine-ditan-now-available-for-prescription-300996903.html. Accessed January 31, 2020.
2. FDA approves new treatment for patients with migraine [press release]. Silver Spring, MD: FDA; Published October 11, 2019. prnewswire.com/news-releases/fda-approves-new-treatment-for-patients-with-migraine-300937273.html. Accessed January 31, 2020.
3. Wietecha L, Kuca B, Asafu-Adjei J, et al. Phase 3 Studies (SAMURAI, SPARTAN) of Lasmiditan Compared to Placebo for Acute Treatment of Migraine (S50.008). Neurology. 2018;90. http://n.neurology.org/content/90/15_Supplement/S50.008.