FDA News

Reyvow approved for acute migraine treatment

The FDA announced it approved Reyvow for the treatment of adults with acute migraine with or without aura.

According to a press release from the agency, approval of Reyvow (lasmiditan, Eli Lilly) was based on two randomized, double-blind, placebo-controlled trials of 3,177 adults with migraine with or without aura undergoing a short-term attack, of whom 22% were taking a preventive medication for migraine.

Compared with those assigned placebo, more patients assigned lasmiditan had their pain and most bothersome symptom — nausea, light sensitivity or sound sensitivity — resolved at 2 hours, the agency stated in the release.

“Reyvow is a new option for the acute treatment of migraine, a painful condition that affects one in seven 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 the release. “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.”

In the trials, the most common side effects of lasmiditan reported were dizziness, fatigue, paresthesia and sedation, and the drug should be used with caution if taken with alcohol or central nervous system depressants, the FDA stated in the release.

Patients should not drive or operate machinery within 8 hours of taking lasmiditan, and those who cannot refrain from doing so should not take the drug, according to the agency.

Disclosure: Kozauer is an employee of the FDA.

The FDA announced it approved Reyvow for the treatment of adults with acute migraine with or without aura.

According to a press release from the agency, approval of Reyvow (lasmiditan, Eli Lilly) was based on two randomized, double-blind, placebo-controlled trials of 3,177 adults with migraine with or without aura undergoing a short-term attack, of whom 22% were taking a preventive medication for migraine.

Compared with those assigned placebo, more patients assigned lasmiditan had their pain and most bothersome symptom — nausea, light sensitivity or sound sensitivity — resolved at 2 hours, the agency stated in the release.

“Reyvow is a new option for the acute treatment of migraine, a painful condition that affects one in seven 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 the release. “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.”

In the trials, the most common side effects of lasmiditan reported were dizziness, fatigue, paresthesia and sedation, and the drug should be used with caution if taken with alcohol or central nervous system depressants, the FDA stated in the release.

Patients should not drive or operate machinery within 8 hours of taking lasmiditan, and those who cannot refrain from doing so should not take the drug, according to the agency.

Disclosure: Kozauer is an employee of the FDA.