Recently Approved Drug Works In Difficult-to-Treat Migraine

Erenumap, approved by the FDA for the preventive treatment of migraine in adults in May 2018, effectively prevents migraine in patients who did not respond to or tolerate 2 to 4 previous preventive treatments, according to the results of a recent study.

Lack of response and intolerance to oral preventive treatments is common among patients with migraine, according to the study authors.

They conducted a 12-week, double-blind, placebo-controlled randomized study involving 246 patients with a history of episodic migraine with or without aura for at least 12 months, had migraine for an average of 4-14 days per month during the 3 months before screening, and had been treated unsuccessfully with 2-4 preventive treatments.

The participants were randomized (1:1) to either erenumab 140 mg (via two 70 mg injections) or placebo every 4 weeks for 12 weeks. The primary endpoint was a 50% reduction in the mean number of monthly migraine days during weeks 9-12.

Overall, 95 of 246 (39%) participants had previously been treated, unsuccessfully, with 2 preventive drugs, 93 (38%) with 3 drugs, and 56 (23%) with 4 drugs.

At 12 weeks, 36 (30%) of the participants in the erenumab group had a 50% or greater reduction from baseline in the mean number of monthly migraine days, compared with 17 (14%) in the placebo group. Safety and tolerability did not differ between the 2 groups. Injection site pain, which occurred in 7 (6%) of participants in both groups, was the most commonly reported adverse event.

“Compared with placebo, erenumab was efficacious in patients with episodic migraine who previously did not respond to or tolerate between two and four previous migraine preventive treatments. Erenumab might be an option for patients with difficult-to-treat migraine who have high unmet needs and few treatment options.”

—Michael Potts

Reference:

Reuter U, Goadsby PJ, Lanteri-Minet M, et al. Efficacy and tolerability of erenumab in patients with episodic migraine in whom two-to-four previous preventive treatments were unsuccessful: a randomised, double-blind, placebo-controlled, phase 3b study [published online October 22, 2018]. Lancet. https://doi.org/10.1016/S0140-6736(18)32534-0.