The U.S. Food and Drug Administration has approved Eli Lilly and Company's Reyvow (lasmiditan) tablets for acute treatment of migraine headaches in adults. Though used colloquially by everyone who feels like their headache is bad, a clinical migraine is an intense throbbing or pulsing pain in one area of the head that often brings nausea and sensitivity to light and sound.
The effectiveness of Reyvow for the acute treatment of migraine was demonstrated in two randomized, double-blind, placebo-controlled trials. A total of 3,177 adult patients with a history of migraine with and without aura treated a migraine attack with Reyvow in these studies.
In both studies, the percentages of patients whose pain resolved and whose most bothersome migraine symptom (nausea, light sensitivity, or sound sensitivity) resolved two hours after treatment were significantly greater among patients receiving Reyvow at all doses compared to those receiving placebo.
Although patients were allowed to take a rescue medication two hours after taking Reyvow, opioids, barbiturates, triptans and ergots were not allowed within 24 hours of the study drug’s administration. Twenty-two percent of patients were taking a preventive medication for migraine.
Other facts:
Miraine affects more than 10% of people worldwide.
Approximately one-third of individuals who suffer from migraine also experience aura (a sensory phenomenon or visual disturbance) shortly before the migraine, which has been reported as flashing lights, zig-zag lines, or a temporary loss of vision.
Migraine is reported three times more often by women than men and affects more than 10% of people worldwide.
Impairment Risk
There is a risk of driving impairment while taking Reyvow. Patients are advised not to drive or operate machinery for at least eight hours after taking Reyvow, even if they feel well enough to do so. Patients who cannot follow this advice are advised not to take Reyvow. The drug causes central nervous system (CNS) depression, including dizziness and sedation. It should be used with caution if taken in combination with alcohol or other CNS depressants.
Side effects
The most common side effects that patients in the clinical trials reported were dizziness, fatigue, a burning or prickling sensation in the skin (paresthesia), and sedation.
Reyvow (Lasmiditan) For Migraine Headaches Gets FDA Approval
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