Philadelphia – according to research presented at the annual meeting of the American Headache Society. Among these benefits are pain relief, pain freedom, freedom from the most bothersome symptom (MBS), and freedom from functional disability. In addition, rimegepant’s safety and tolerability are similar to those of placebo. Results of the study were published simultaneously in the New England Journal of Medicine.
Rimegepant is a calcitonin gene–related peptide (CGRP) receptor antagonist. The small-molecule drug is administered as an oral tablet. It provided effective acute treatment of migraine in several phase 3 studies. A new ODT formulation of rimegepant reaches peak serum concentration approximately 30 minutes sooner than the tablet does and thus could provide quicker therapeutic onset, according to new data.
, the Edwin S. Lowe chair in neurology at Albert Einstein College of Medicine in New York, and colleagues conducted a double-blind, multicenter, phase 3 trial to compare the efficacy, safety, and tolerability of rimegepant 75 mg ODT with those of placebo in the acute treatment of migraine. Eligible participants were aged 18 years or older and had a 1-year history of migraine. After screening potential participants, the investigators randomized patients to 75 mg of rimegepant in an ODT or placebo. Participants were told to treat a single migraine attack of moderate or severe pain intensity. The investigators chose 2-hour pain freedom and freedom from the MBS as their two primary endpoints. The study’s safety assessments included adverse events, ECG, vital signs, and routine laboratory tests.
Dr. Lipton and colleagues randomized and treated 1,186 participants, and 1,072 were evaluated for efficacy. In the efficacy analysis, the rimegepant ODT group included 537 patients, and the placebo group included 535 patients. The population’s mean age was 40.6 years, and 88.7% of the sample was female.
The proportion of patients who were pain-free at 2 hours after treatment was 19.6% in the rimegepant ODT arm and 12.0% among controls. Approximately 37.6% of participants in the rimegepant ODT arm achieved freedom from the MBS, compared with 25.2% of controls.
Dr. Lipton and colleagues also assessed participants’ outcomes at additional time points. They found that rimegepant ODT was superior to placebo at 60 minutes after treatment for pain relief and freedom from functional disability. Also, at 90 minutes after treatment, rimegepant ODT was superior to placebo for pain freedom and freedom from the MBS.
Furthermore, a single dose of rimegepant ODT, without rescue medication, was superior to placebo through 48 hours post dose for sustained pain freedom, sustained pain relief, sustained freedom from the MBS, and sustained freedom from functional disability. Most participants in the rimegepant ODT group (85.8%) did not use rescue medication within 24 hours after treatment. Overall, rimegepant ODT was superior to placebo on 21 prespecified, hierarchically tested endpoints.
The safety and tolerability profiles of rimegepant ODT were similar to those of placebo. The most common adverse events were nausea (1.8% for rimegepant vs. 1.1% for placebo) and urinary tract infection (1.5% for rimegepant vs. 1.1% for placebo). No participants in either treatment group had a transaminase level greater than three times the upper limit of normal. No participant in either group had elevations in bilirubin greater than two times the upper limit of normal. The investigators observed serious adverse events (such as back pain) in one treated participant and two controls.
The study was supported by Biohaven, which is developing rimegepant. Dr. Lipton has received consulting fees from the company, and several of the other investigators are employees of the company.
SOURCE: Lipton RB et al. .