Nurtec ODC allows for new 'adaptive' approach to individual migraine treatment needs

Oral Nurtec ODT 75 mg taken every other day effectively prevented migraines, according to results of a randomized, double-blind, placebo-controlled trial presented at the American Headache Society Virtual Annual Scientific Meeting.

Nurtec ODT (rimegepant; Biohaven) may offer an adaptable treatment method that can be tailored to an individual’s treatment needs, a presenter noted.

“[This study] compared the efficacy, safety and tolerability of Nurtec ODC given every other day with placebo as a preventive treatment for migraine,” Robert Croop, MD, of Biohaven Pharmaceuticals Inc. in Connecticut, said during a virtual presentation. “The screening and eligibility criteria indicate that adults with at least 1 year of migraine and four to 18 moderate or severe attacks per month were eligible. This study had a typical 28-day baseline observation period, a 12-week double-blind phase and then a 52-week open-label extension phase.”

A total of 370 participants received Nurtec ODC 75 mg every other day and 371 received placebo every other day during the 12 weeks of double-blind treatment. Of the total study participants, 82.7% were women and the mean age was 41 years. Overall, 23% of the sample had chronic migraine and 40% met criteria for chronic migraine with aura. The researchers balanced the two treatment groups with respect to these characteristics. Change in monthly migraine days from baseline to weeks 9 through 12 served as the primary efficacy variable.

Results showed a 4.3-day reduction for Nurtec ODC and a 3.5-day reduction for placebo in the primary efficacy variable. According to Croop, this reduction represented a “highly statistically significant” difference.

Nurtec ODC demonstrated superiority to placebo on secondary efficacy endpoints. A total of 49% of Nurtec ODC-treated participants and 41% of those who received placebo achieved a greater than or equal to 50% reduction in the mean number of moderate or severe monthly migraine days in weeks 9 through 12. Those who received Nurtec ODC had a 3.6-day reduction compared with a 2.7-day reduction among those who received placebo in mean change in number of total monthly migraine days across weeks 1 through 12. Croop and colleagues observed similar statistically significant differences in the episodic and chronic migraine subgroups.

Regarding preventive efficacy observed over the first week of Nurtec ODC treatment according to mean percentage change from the baseline observation period, the researchers found a 30% reduction in migraine days per week in the Nurtec ODC arm and a 9.4% reduction in the placebo arm.

Participants in both groups were equally likely to experience an adverse event, nearly all of which were mild or moderate in intensity, according to Croop. The most common adverse events that occurred in 2% or more of participants were nasal pharyngitis, nausea, urinary tract infection and upper respiratory tract infection. They observed “no signal” of hepatotoxicity or constipation.

“These preventive results, along with the previously established acute treatment efficacy of Nurtec ODT, suggests that this drug may provide a new approach to treating migraine in an adaptive way, depending on the individual treatment needs for acute or preventive treatment,” Croop said. “How this opportunity to use the same drug as an acute and as a preventive treatment will work out in practice remains to be determined, but the opportunities for flexible therapy and giving preventive treatment when needed and switching to acute treatment when it's not necessary will create new opportunities for all of us to help our patients with migraine.”