Efficacy, Safety, Tolerability, and Pharmacoeconomic Value Data for Rimegepant Presented
Data from multiple clinical trials and extension studies on the use of rimegepant (Nurtec; Biohaven Pharmaceutical, New Haven, CT) have been made available on the 2020 American Academy of Neurology (AAN) Science Highlights virtual meeting platform.
Vlad Coric, MD, chief executive officer of Biohaven commented, "The large number of important clinical and health economic analyses highlight Biohaven's leadership and commitment to advancing Nurtec with the goal of gaining approval as the first oral CGRP-targeting agent for both the acute and preventive treatment of migraine. The data presented add to the growing body of scientific evidence supporting Nurtec ODT as a differentiated treatment for migraine with a depth of response in several patient populations, including those who have tried triptans and those using migraine preventive treatment who are in need of effective acute therapy for breakthrough attacks."
Dr. Coric added, "Nurtec ODT is the only CGRP-targeting drug to have return to normal functioning within hours and sustained efficacy out to 48 hours after a single dose in the approved drug label.."
- Treatment with rimegepant, which is a calcitonin gene-related peptide (CGRP) inhibitor for acute treatment, while also using an intramuscular monoclonal antibody CGRP inhibitor for preventive treatment was highly tolerable with no safety issues.
- For triptan-experienced participants (those who had found triptans ineffective or who were using triptans at enrollment), treatment with 75 mg of rimegepant provided more freedom from pain, more freedom from most bothersome symptom (MBS), and pain relief 2 hours postdose compared with placebo.
- In pooled data analysis, a single oral dose of rimegepant 75 mg (n=1,749) without repeat dosing or rescue medication was superior to placebo (n=1,758) for sustained pain relief and ability to function normally from 2 to 48 hours after taking the medication. Some people who took rimegepant had pain relief as early as 15 minutes after taking the medication. Effects were statistically superior to placebo on pain relief and ability to function normally 1 hour after taking a dose.
- Acute migraine treatment as needed with a single dose of rimegepant (75 mg) significantly improved absenteeism (ABS), presenteeism (PBS), and lost productivity time (LPT) by 44%, reflecting improvements in workplace productivity over a 52-week period.
- Monthly migraine days (MMD) were reduced in in participants with 2 to 8 MMD or 9 to 14 MMD who took a single dose of rimegepant (75 mg) as needed. Individuals with 4 to 14 MMD who took 75 mg of rimegepant every other day and as needed also had reductions in MMD.