Biohaven Pharmaceutical’s FDA-approved pill to treat migraine attacks is showing that it can prevent such headaches too.
According to preliminary results from a late-stage trial released Monday, the Biohaven drug beat a placebo at reducing the average number of days per month patients with chronic and episodic migraine experienced the debilitating condition.
The FDA OK’d the drug, rigemepant (Nurtec), as a treatment for acute migraine about a month ago. Based on the new results released Monday, the New Haven, CT-based company plans to ask regulators to approve expansion of the drug’s approval to cover migraine prevention.
Rimegepant is part of a new class of migraine drugs that block calcitonin gene-related peptide (CGRP), a protein whose levels increase during a migraine attack. Speaking on a conference call Monday, CEO Vlad Coric said the results of the trial make rimegepant the only therapy targeting CGRP that has proved effective against acute migraine and as a preventive treatment. Given that, he suggested the pill, if approved as a prevention measure, could reduce the number of medicines patients with migraines have to take and, given its oral formulation, eliminate the need for injections.
Three CGRP drugs developed to prevent migraine headache pain before it starts—all injectables—got the FDA’s nod in 2018. Eli Lilly’s galcanezumab (Emgality) was among them. Last October, the FDA approved a separate Lilly (NYSE: LLY) drug, lasmiditan (Reyvow), to address acute migraine. (That drug works by targeting and activating a receptor called 5-HT1F, not blocking CGRP.)
Lundbeck’s eptinezumab (Vyepti), another CGRP drug for migraine prevention, was approved last month; it is delivered as an intravenous infusion. Besides Biohaven, Allergan (NYSE: AGN) has the only other FDA-approved CGRP drug that comes in pill form. But approval of that drug, ubrogepant (Ubrelvy), covers only treatment of acute migraine.
Biohaven enrolled a total of 741 patients in the rimegepant trial, and assessed the efficacy, safety, and tolerability of the drug compared to a placebo at the end of 12 weeks. Patients in a one-month observation period before the start of the study experienced an average of 10.7 migraine days, and on 7.4 of those days experienced migraine pain they considered moderate to severe.
After three months of rimegepant treatment, which is given every other day in 75 mg doses, the drug met the main goal of the study, which was to demonstrate a comparatively statistically significant reduction from the number of migraine days patients typically experienced. Those in the rimegepant group saw the average number per month fall by 4.5 days, compared to 3.7 days in the placebo group. Forty-eight percent of patients in the rimegepant group saw a reduction from baseline of at least 50 percent in the average number of moderate to severe migraine days per month, compared to 41 percent in the placebo group.
About 22 percent of patients in the study continued to take other preventative treatments. Among those who weren’t taking other medicines to prevent migraine, the reduction in monthly migraine days was 4.9 days compared with 3.7 days per month in the placebo group.
Biohaven said the safety profile of the drug was consistent with the results of prior clinical trials, in which the most common side effects were nausea and hypersensitivity, including shortness of breath and rash. The company plans to present data from the trial at upcoming medical meetings. Read more here about the development of rimegepant, which Biohaven licensed from Bristol Myers Squibb (NYSE: BMY) in 2016.
Image: iStock/Tero Vesalainen