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Officials with the FDA have approved lasmiditan (Reyvow, Eli Lilly) tablets for the acute treatment of migraine with or without aura in adults, according to the agency.
Migraines can cause debilitating symptoms, such as intense throbbing or pulsing pain in 1 area of the head, nausea and/or vomiting, and sensitivity to light and sound. Approximately one-third of individuals who suffer from migraine also experience aura, which can appear as flashing lights, zig-zag lines, or a temporary loss of vision shortly before the migraine occurs.
Lasmiditan is an oral, centrally-penetrant, selective serotonin 5-HT1F agonist that is structurally and mechanistically distinct from other approved migraine therapies, according to Lilly. Unlike other therapies on the market, lasmiditan has been designed to treat migraines without vasoconstrictor activity, according to a press release. Upon submission of lasmiditan’s new drug application, Lilly stated that the approval of the drug would be “the first significant advancement for the acute treatment of migraine in more than 2 decades.”
The approval is backed by efficacy and safety data from 2 clinical trials, SAMURAI and SPARTAN, which included 3177 adult patients with a history of migraine with and without aura. Patients treated their migraine attacks with either lasmiditan (50 mg, 100 mg, or 200 mg) or placebo in both studies. A significantly greater rate of patients treated with lasmiditan experienced pain and bothersome symptom resolution within 2 hours than those who received a placebo. These results were significant across all studied doses. The most commonly reported adverse events in the study were dizziness, paresthesia, somnolence, fatigue, nausea, muscle weakness, and numbness.
Although patients were allowed to take a rescue medication 2 hours after taking lasmiditan, opioids, barbiturates, triptans, and ergots were not allowed within 24 hours of the drug’s administration. Twenty-two percent of patients in the studies were taking preventive medication for migraine. In a post-hoc analysis of the pooled phase 3 studies, it was found that patients taking lasmiditan showed improvements regardless of prior experience with triptans.
Overall, the lasmiditan phase 3 program included more than 4000 patients and 20,000 migraine attacks.
“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 of the Division of Neurology Products in the FDA’s 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.”
According to the FDA, patients are not advised to drive or operate machinery at least 8 hours after taking lasmiditan due to an increased risk of driving impairment.
Lasmiditan is not indicated for the preventive treatment of migraine.
References
FDA approves new treatment for patients with migraine [news release]. FDA’s website. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-patients-migraine. Accessed October 11, 2019.
Lilly Submits New Drug Application to the FDA for Lasmiditan for Acute Treatment of Migraine, Receives Breakthrough Therapy Designation for Emgality (galcanezumab-gnlm) for Prevention of Episodic Cluster Headache [news release]. Eli Lilly’s website. https://investor.lilly.com/news-releases/news-release-details/lilly-submits-new-drug-application-fda-lasmiditan-acute. Accessed October 11, 2019.
Migraines can cause debilitating symptoms, such as intense throbbing or pulsing pain in 1 area of the head, nausea and/or vomiting, and sensitivity to light and sound. Approximately one-third of individuals who suffer from migraine also experience aura, which can appear as flashing lights, zig-zag lines, or a temporary loss of vision shortly before the migraine occurs.
Lasmiditan is an oral, centrally-penetrant, selective serotonin 5-HT1F agonist that is structurally and mechanistically distinct from other approved migraine therapies, according to Lilly. Unlike other therapies on the market, lasmiditan has been designed to treat migraines without vasoconstrictor activity, according to a press release. Upon submission of lasmiditan’s new drug application, Lilly stated that the approval of the drug would be “the first significant advancement for the acute treatment of migraine in more than 2 decades.”
The approval is backed by efficacy and safety data from 2 clinical trials, SAMURAI and SPARTAN, which included 3177 adult patients with a history of migraine with and without aura. Patients treated their migraine attacks with either lasmiditan (50 mg, 100 mg, or 200 mg) or placebo in both studies. A significantly greater rate of patients treated with lasmiditan experienced pain and bothersome symptom resolution within 2 hours than those who received a placebo. These results were significant across all studied doses. The most commonly reported adverse events in the study were dizziness, paresthesia, somnolence, fatigue, nausea, muscle weakness, and numbness.
Although patients were allowed to take a rescue medication 2 hours after taking lasmiditan, opioids, barbiturates, triptans, and ergots were not allowed within 24 hours of the drug’s administration. Twenty-two percent of patients in the studies were taking preventive medication for migraine. In a post-hoc analysis of the pooled phase 3 studies, it was found that patients taking lasmiditan showed improvements regardless of prior experience with triptans.
Overall, the lasmiditan phase 3 program included more than 4000 patients and 20,000 migraine attacks.
“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 of the Division of Neurology Products in the FDA’s 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.”
According to the FDA, patients are not advised to drive or operate machinery at least 8 hours after taking lasmiditan due to an increased risk of driving impairment.
Lasmiditan is not indicated for the preventive treatment of migraine.
References
FDA approves new treatment for patients with migraine [news release]. FDA’s website. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-patients-migraine. Accessed October 11, 2019.
Lilly Submits New Drug Application to the FDA for Lasmiditan for Acute Treatment of Migraine, Receives Breakthrough Therapy Designation for Emgality (galcanezumab-gnlm) for Prevention of Episodic Cluster Headache [news release]. Eli Lilly’s website. https://investor.lilly.com/news-releases/news-release-details/lilly-submits-new-drug-application-fda-lasmiditan-acute. Accessed October 11, 2019.
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