FDA Approves New Medicine for Acute Treatment of Migraine

FDA has approved a new medicine for the acute treatment of migraine. Reyvow (lasmitidan) tablet is effective for active but short term treatment of patients with migraine. But it isn’t designated as a preventive measure. Still, Reyvow can treat migraine with or without aura in adults. Whereas, an aura is a visual disturbance or sensory phenomenon.

Reyvow – a new and effective option for migraine

Nick Kozauer is acting deputy director of the Division of Neurology Products and M.D. in the Center for Drug Evaluation and Research, FDA. He stated that Reyvow is a new and better option for acute treatment of migraine. And migraine is a painful state that affects one in every seven Americans.

Moreover, he also said that the migraine community has a keen interest in additional options for treating migraines. And the FDA’s Center for Drug Evaluation and Research has remained committed to continue its work with stakeholders for promoting the development of new options for the preventive and acute treatment of migraines.

Migraine is a headache, often described as an intense pulsing or throbbing pain in one area around the head. The symptoms may include sensitivity to light and sound, nausea, and vomiting. Moreover, nearly one-third of the patients suffering from this condition also experience an aura, shortly before the occurrence of migraine.

An aura may appear as zig-zag lines, flashing lights, or a temporary loss of vision. Various factors like bright or flashing lights, hormonal changes, stress, lack of food or sleep, and diet can trigger a migraine. The incidence of migraine is three times more in women than in men. And globally, it affects more than 10% of the population.

Two randomized, placebo-controlled, and double-blind trials have shown the effectiveness of Reyvow for the acute treatment of migraine. These studies have used Reyvow to treat a total of 3,177 adult patients with a history of migraine, with and without aura. The researchers have observed the proportion of patients whose most bothersome migraine symptoms and pain resolved two hours after treatment.

Related: Safety Warnings Issued the FDA for Unsafe Dietary Supplements Containing Vinpocetine

Risks associated with the use of Reyvow

In both studies, the proportion was quite greater in the case of patients receiving Reyvow at various doses than those receiving placebo. The researchers have permitted patients to take rescue medicine after taking Reyvow. But forbidden the use of barbiturates, triptans, opioids, and ergots within 24 hours of administration of the study drug.

About 22% of the patients were having a preventive therapy for migraine. The experts haven’t advised the patients with migraine to operate machinery or drive for at least eight hours after taking Reyvow, due to the risk of driving impairment associated with it. So, patients who can’t follow this advice aren’t recommended to take Reyvow.

This drug causes CNS – central nervous system depression, including sedation and dizziness. So, it needs caution while using Reyvow in combination with other CNS depressants or alcohol. The most common side effects associated with this medicine during the clinical trial were fatigue, dizziness, sedation, and a burning or prickling sensation in the skin (paresthesia).

The FDA is an agency that works for public health by ensuring the effectiveness, safety, and security of human and veterinary drugs, vaccines, and medical devices. It has given the approval of Reyvow to Eli Lilly and Company.

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