Lasmiditan, First Oral Serotonin 5-HT1F Receptor Agonist or Ditan, Available for Prescription
American Headache Society shares breaking news regarding new treatments approved or cleared by the FDA
On January 31, 2020, lasmiditan (REYVOY™) producer Eli Lilly and Company announced the 5-HT1F receptor agonist, or ditan, is now available for prescription and will soon be available in pharmacies after receiving a Schedule V classification. This is the first and only 5-HT1F receptor agonist approved by the FDA.
“As new migraine-specific medications are scheduled by the FDA, this next generation of migraine therapies offers hope to those with this disabling disease,” says Amaal Starling, MD, FAHS, assistant professor of neurology at the Mayo Clinic and member of the American Headache Society. “Lasmiditan, the first and only serotonin 5-HT1F receptor agonist approved by the FDA, follows the approval of gepants in the evolution of migraine treatments.”
Two randomized, double-blind, placebo-controlled, single-attack trials (SAMURAI and SPARTAN) demonstrated the efficacy of orally-administered lasmiditan. Compared to the placebo, the 50 mg, 100 mg and 200 mg dose strengths demonstrated greater rates of pain freedom and freedom from the most bothersome migraine-associated symptoms such as nausea, hypersensitivity to light and hypersensitivity to sound at two hours.
The most common adverse events reported included dizziness, fatigue, paresthesia, sedation, nausea and/or vomiting and muscle weakness. Two driving studies were conducted to assess the impact of lasmiditan. Results show that lasmiditan may cause significant driving impairment. Additionally, more sleepiness was reported at eight hours compared to the placebo.
Lasmiditan presumably exerts its therapeutic effects by activating the Serotonin (5-HT1F) receptor. However, the precise mechanism is unknown. Lasmiditan is non-opioid, non-narcotic, Schedule V and has low abuse potential.
For more information about lasmiditan that can be used to inform treatment decisions, click here.
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