Eli Lilly’s lasmiditan (Reyvow) tablets are the first member of the ditan class approved for use in adults with migraine with or without aura, offering patients who have an inadequate response to other therapies a new acute treatment option.
Richard Lipton, MD
The FDA has granted approval to Eli Lilly for its oral, centrally-penetrant, selective serotonin 5-HT1F agonist lasmiditan (Reyvow) for the acute treatment of migraine with or without aura in adults.1
The regulatory decision was backed by the findings of 2 phase 3, single-attack clinical trials—SAMURAI and SPARTAN—which suggested that lasmiditan tablets were associated with a high rate of pain-freedom from migraine as well as freedom from the most bothersome symptom.
"Reyvow is a new option for the acute treatment of migraine, a painful condition that affects 1 in 7 Americans," Nick Kozauer, MD, acting deputy director, Division of Neurology Products, FDA Center for Drug Evaluation and Research, said in a statement. "We know that the migraine community is keenly interested in additional treatment options, and we remain committed to continuing to work with stakeholders to promote the development of new therapies for the acute and preventive treatment of migraine."
Lasmiditan is the first and only molecule in the ditan class approved for the treatment of migraine in adults. Clinical development of lasmiditan included more than 3100 patients with a history of migraine with and without aura, of which 22% were taking preventive migraine medication.
Study results demonstrated that the percentage of patients who received lasmiditan 200 mg (P <.001) who were migraine pain-free at 2 hours after dosing was significantly greater than placebo (lasmiditan 200 mg: SAMURAI 32.2%, SPARTAN 38.8% vs placebo: SAMURAI 15.3%, SPARTAN 21.3%). Additionally, the second endpoint was also met, with a significantly greater percentage of patients free of their most bothersome symptom, either sensitivity to light, or sensitivity to sound or nausea, compared with placebo at 2 hours post-first dose (lasmiditan 200 mg: SAMURAI 40.7%, SPARTAN 48.7% vs placebo: SAMURAI 29.5%, SPARTAN 33.5%).2
In a recent conversation with NeurologyLive, Richard Lipton, MD, the Edwin S. Lowe Professor and vice chair of neurology, a professor of epidemiology and population health, and a professor of psychiatry and behavioral sciences at the Albert Einstein College of Medicine, and director of the Montefiore Headache Center, both in Bronx, New York, shared insight into the advantages that lasmiditan may offer patients looking for acute relief.
“I think lasmiditan will be the treatment of choice particularly for people who have migraine at night that interferes with sleep,” Lipton said. “If you have a migraine and it’s bedtime and you want a little relief of headache, you won’t really mind taking a drug that might cause a little bit of sedation because you’ll sleep 8 hours and wake up in the morning and be able to drive to work.” The drug is associated with a risk of driving impairment, with the most frequently reported treatment-emergent adverse events being dizziness, fatigue, lethargy, nausea, paresthesia, and somnolence.
Lipton also told NeurologyLive that the therapy will most likely play a role for those who do not respond to treatment with gepants. He explained that this drug class is similar to that of CGRP-targeted therapies in that they are not vasoconstrictors. “On that basis, we believe that gepants and ditans are likely to be free of the cardiovascular issues that have limited the use of triptans,” Lipton said.
1. 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 October 11, 2019.
2. 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.