The oral calcitonin gene-related peptide receptor antagonist was approved in late February and comes in 8-tablet packs for treatment of 8 migraine attacks with a single, 75-mg dose.
Biohaven announced that its newly approved oral calcitonin gene-related peptide (CGRP) receptor antagonist rimegepant (Nurtec ODT) is now available for prescription in pharmacies across the United States.1
The agent was approved by the FDA for its indication on February 27. It disperses almost instantly in a person's mouth without the need for water, according to Biohaven.
“At Biohaven, helping those with migraine is personal to us. We understand the widespread and debilitating effects that patients experience,” BJ Jones, MBA, MS, chief commercial officer for migraine and common diseases, Biohaven, said in a statement. “The urgency to provide new treatment options for the millions who live with it each day has underscored our efforts to bring NURTEC ODT to pharmacies quickly."
Biohaven stated it seeks to ensure improved patient access, and thus developed a comprehensive suite of affordability and access programs for patients, which can be found by calling 1-833-4NURTEC, or by visiting the website, www.nurtec.com, and its Twitter community. “Biohaven is dedicated to minimizing barriers to medication access for people with migraine and has developed a suite of programs to help patients and physicians process access to NURTEC ODT,” Jones added.
Each 8-tablet pack of rimegepant covers the treatment of 8 migraine attacks with a single, 75-mg dose, as needed, up to once daily. Biohaven will make sample packs containing 2 tablets available to health care professionals.
Rimegepant’s approval was granted based on the results of 2 clinical trials: the phase 3 Study 303 and the long-term, open-label safety trial, Study 201. Rimegepant achieved statistical significance on the co-primary endpoints of pain freedom and freedom from the most bothersome symptom (MBS) at 2 hours post-dose compared to placebo. Additionally, the treatment demonstrated statistical superiority at 1 hour for pain relief and return to normal function.2
In its clinical development, more than 3100 patients were treated with more than 113,000 doses of the therapy. Overall, rimegepant was generally well tolerated; the most common adverse event (AE) was nausea, which occurred in 2% of patients who received therapy compared to 0.4% of patients who received placebo.
In data presented at the 2019 American Academy of Neurology Annual Meeting of Study 303 Freedom from pain at 2 hours posttreatment was achieved for 21.2% of patients in the ODT rimegepant arm compared with 10.9% of those in the placebo group (P <.0001). Moreover, the patient-reported most bothersome symptom (MBS) at 2 hours was significantly reduced in the rimegepant group (35.1% vs 26.8%; P = .0009).2
Pain relief was achieved at 60 minutes for 36.8% of patients in the ODT arm compared with 31.2% in the placebo group (P = 0.314). At 90 minutes, half of the patients in the rimegepant arm experienced pain relief (49.6%) compared with 37.2% in the placebo arm (P <.0001). Pain relief at 2 hours was 59.3% versus 43.3%, for rimegepant and placebo, respectively (P <.0001).
In Study 303, sustained pain relief was achieved for 47.8% and 27.7% of patients for 2-24 hours and for 42.2% and 25.2% for 2-48 hours, in the rimegepant and placebo groups, respectively (P <.0001). Sustained freedom from MBS was achieved for 27.1% and 17.7% for 2-24 hours and for 23.2% and 16.4% for 2-48 hours, for rimegepant and placebo groups, respectively (P <.01).
The ability to function normally returned for 38.1% of patients at 2 hours in the rimegepant arm compared with 25.8% in the placebo group. Moreover, there was a lower probability of requiring rescue medications in the rimegepant arm compared with placebo (14.2% vs 29.2%).
1. Biohaven's NURTEC(TM) ODT (rimegepant 75mg) is Now Available in U.S. Pharmacies for the Acute Treatment of Migraine in Adults [press release]. New Haven, CT: Biohaven; Published March 12, 2020. Accessed March 13, 2020. ptcommunity.com/wire/biohavens-nurtectm-odt-rimegepant-75mg-now-available-us-pharmacies-acute-treatment-migraine
2. Lipton RB, Coric V, Stock EG, et al. Efficacy, Safety, and Tolerability of Rimegepant 75 mg Orally Dissolving Tablet for the Acute Treatment of Migraine: A Phase 3 Double-Blind, Randomized, Placebo-Controlled Trial (Study 303). Presented at: 2019 American Academy of Neurology Annual Meeting. May 4-10, 2019; Philadelphia, PA. Poster 075.