FDA Approves New Lilly Migraine Drug

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved Eli Lilly’s Reyvow (lasmiditan) for the treatment of migraine with or without aura. Reyvow is the first migraine treatment that acts by binding to serotonin receptors in the brain and depressing central nervous system activity. 

“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 FDA’s Division of Neurology Products, 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.”  

Migraine affects a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. In addition to headache pain and nausea, migraine can cause blurriness, light sensitivity and visual disturbances known as aura.

The effectiveness of Reyvow tablets was demonstrated in two double-blind, placebo-controlled studies involving nearly 3,200 patients experiencing a migraine attack. In one study, only about 32% of patients receiving 200mg of Reyvow were pain free after two hours, but that compares to 15% taking a placebo — enough to be considered statistically significant.


"As a physician who specializes in the treatment of migraine and headache disorders, I commonly treat patients who are looking for acute treatment options that offer the chance for pain freedom during migraine attacks. This approval is especially significant because migraine pain is so often severe and incapacitating," said Jan Brandes, MD, a neurology professor at Vanderbilt University and paid consultant to Lilly.

The most common side effects for patients in the Reyvow clinical trials were dizziness, fatigue, a burning or prickling sensation in the skin (paresthesia), and sedation.  An FDA warning label will caution patients not to drive or operate machinery for at least eight hours after taking Reyvow. The drug should also not be taken with alcohol or other serotonin depressants.

Reyvow is not approved for the preventive treatment of migraine. Lilly did not say when Reyvow would be available or how much it would cost.

In recent years, the FDA has approved several new migraine therapies, including injectable drugs to prevent migraine and neuromodulation devices that use electrical pulses to disrupt pain signals.

Migraine can be triggered by various factors including stress, hormonal changes, bright or flashing lights, lack of food or sleep, and diet. Women are three times more likely to suffer from migraine than men.