Rimegepant Demonstrates Efficacy in Prevention of Migraine

Oral rimegepant demonstrated significant superiority compared with placebo in reducing monthly migraine days, according to results from a clinical tiral.  

Rimegepant (Nurtec ODT, Biohaven Pharmaceuticals), a calcitonin gene-related peptide (CGRP) receptor antagonist, is approved for the acute treatment of migraine in adults with or without aura. However, it is not currently indicated for the preventive treatment of migraine.

The study evaluated the efficacy and safety of oral rimegepant 75 mg for the preventive treatment of migraine in patients with both episodic and chronic migraine. Patients included in the study had migraine for at least 1 year and 4 to 18 moderate-to-severe migraine attacks per month over 3 months prior to enrollment. Rimegepent 75 mg was dosed every other day versus placebo.

The results showed:

• Overall, patients receiving rimegepant 75 mg very other day (n=348) experienced a statistically significant 4.5 day reduction from baseline in monthly migraine days, compared with a 3.7 day reduction in the placebo group (n=347; p=0.0176).

• Among patients not taking comcomitant preventive treatment, there was a 4.9 day reduction in monthly migraine days in the rimegepant group (n=273) compared with a 3.7 day reduction in the placebo group (n=269; nominal p=0.0020), according to the study.

• A total of 22% of the patients in the study were taking a concurrent preventive treatment, including topiramate and amitriptyline.

• Forty-eight percent of the rimegepant group had at least a 50% reduction from baseline in the mean number of moderate-to-severe migraine days per month compared with 41% in the placebo group.

Based on these data, the study met the primary endpoint, demonstrating a statistically significant reduction from baseline in monthly migraine days in patients treated with rimegepant compared with placebo.

Additionally, the safety profile observed in the 370 patients who received rimegepant 75 mg every other day was consistent with prior clinical trial experience.

According to Biohaven, rimegepant is the first CGRP targeting therapy to complete pivotal trials that demonstrate its efficacy in both the acute and preventive treatment of migraine.

“I see many patients who are discouraged by the limited current preventive treatment options and continue to look for a better way to prevent disabling attack,” Richard B. Lipton, MD, professor and vice chair of neurology at the Albert Einstein College of Medicine and Montefiore Health System, director of the Montefiore Headache Center, said in a statement. “This is the first time that patients may be able to use a single drug for both acute and preventive treatment. Particularly impressive is the fact that the primary outcome measure of reduction in monthly migraine days was achieved with every other day dosing. I believe that rimegepant will fulfill significant unmet needs for my patents as an oral agent that provides acute and preventive treatment benefits.”

References:

1. Biohaven Achieves Positive Results in Pivotal Trial of Oral Nurtec, Dosed Every Other Day, for the Preventive Treatment of Migraine [news release]. Biohaven Pharmaceutical’s website. https://www.biohavenpharma.com/investors/news-events/press-releases/03-30-2020. Accessed April 2, 2020.