Subjects ” Migraines and headaches
The Food and Drug Administration (FDA) has extended the approval of Nurtec® ODT (Rimegepant) to the preventive treatment of episodic migraines in adults. So far, the oral calcitonin gene-related peptide receptor (CGRP) antagonist has only been indicated for the acute treatment of migraines with or without aura.
The approval was based on data from a randomized, double-blind, placebo-controlled phase 2/3 study (ClinicalTrials.gov Identifier: NCT03732638), in which the efficacy and safety of rimegepant in adults with migraines for at least 1 year and 4 years. rated up to 18 moderate to severe migraine attacks per month for 3 months prior to enrollment in the study. Patients were randomized to receive rimegepant 75 mg orally every other day (n = 373) or placebo (n = 374). The primary endpoint was the change from baseline in the mean number of monthly migraine days (MMDs) over weeks 9 through 12 of the double-blind treatment period.
The results showed that treatment with rimegepant compared with placebo resulted in a statistically significant reduction in MMDs from baseline (-4.3 days vs. -3.5 days; P <0.010). In addition, a larger percentage of patients treated with rimegepant achieved a reduction of at least 50% from baseline in weeks 9 to 12 of the double-blind treatment phase in moderate to severe MMDs (49.1% vs. 41.5%; P = 0.044) . In terms of safety, the most commonly reported adverse reactions were nausea and abdominal pain / dyspepsia.
Continue reading
Commenting on the expanded approval, Peter J. Goadsby, MD, PhD, DSc, professor of neurology at the University of California, Los Angeles and King’s College London and co-author of the phase 3 prevention study published in The Lancet said: ” To “have 1 drug that patients can use to treat and prevent migraines is likely to change the treatment paradigm for many of the millions of people living with migraines.”
Nurtec ODT is supplied as an orally disintegrating tablet with 75 mg rimegepant. For the preventive treatment of episodic migraines, Nurtec ODT is given every other day (up to 18 doses / month).
References
- FDA approves Nurtec® ODT (Rimegepant) from Biohaven for prevention: Now the first and only migraine drug for both acute and preventive treatment. [press release]. New Haven, CT: Biohaven Pharmaceutical; 05/27/2021.
- Nurtec ODT [package insert]. New Haven, CT: Biohaven Pharmaceutical; 2021.
This article originally appeared on MPR
Subjects:
Migraines Migraines and Headache Pain Treatments
Would you like to read more?
Please log in or register first to view this content.
Login Register
to open
Next post in Migraines and Headaches
Shut down
Include more information on Nurtec ODT approval expanded to include Migraine Prevent
Loading… 
Include more information on Nurtec ODT approval expanded to include Migraine Prevent
Loading…
Include more information on Nurtec ODT approval expanded to include Migraine Prevent
Loading…
Include more information on Nurtec ODT approval expanded to include Migraine Prevent
Loading…
Would you like to see more content from Neurology Advisor?
Register now for free to access unlimited clinical news with personalized daily tips for you, Full-length features, case studies, conference coverage, and more.
{{login-button}} {{register-button}}
Would you like to read more?
Please log in or register first to view this content.
Login Register
