Rimegepant Safe in Patients With Prior Triptan Failure
Serious adverse events occurred in 3.7% and 2.4% of subjects in the subgroups of patients with 1 and 2 or more triptan failures, respectively.
Data from a long-term, open-label safety study (NCT03266588) of adults with migraine and a history of triptan treatment failure revealed that long-term treatment with rimegepant 75 mg (Nurtec ODT; Biohaven) up to once daily is safe and well-tolerated.
Kathleen B Mullin, MD, medical director, clinical research, New England Institute for Clinical Research, presented the data at the
A total of 1800 individuals with 4 to 14 severe monthly migraine attacks were assigned to scheduled dosing of Rimegepant 75 mg every other day for 12 weeks supplemented by as needed dosing on nonscheduled dosing days. Of those, 546 (30.3%) had a history of treatment failure with 1 triptan and 246 (13.7%) had failed 2 or more triptans.
Upper respiratory tract infection (1 triptan: 9.5%; ≥2 triptans: 8.9%), nasopharyngitis (1 triptan: 7.9%; ≥2 triptans: 8.1%) and sinusitis (1 triptan: 4.6%; ≥2 triptans: 8.1) were among the most common adverse events (AEs) observed.
A total of 1.6% and 2.0% of patients who had a history of treatment failure with 1 or 2 or more triptans discontinued rimegepant treatment due to AEs, respectively. Serious AEs occurred in 3.7% of subjects who had a history with 1 triptan failure, compared to 2.4% of those with at least 2 or more. None of these were considered to be related to treatment with rimegepant.
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Mullin previously published data in January 2020 that explored the use of
Rimegepant, an orally administered small molecule calcitonin-related peptide (CGRP) receptor antagonist, was used for 6 months prior to initiating 70-mg erenumab monthly in Patient 1 and was used for 60 days before beginning 140-mg erenumab monthly in Patient 2. This was the first clinical report documenting that 2 CGRP therapies can be used this way. Although the data was an exciting first step, Mullin and colleagues noted at the time that, “the mechanism underlying the benefits of concomitant use of a small molecule CGRP receptor antagonist and an anti-CGRP receptor antibody is unknown and requires further study.”
In October 2020, Biohaven announced that its
The
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REFERENCES
1. Mullin KB, Hutchinson S, Smith T, et al. Long-term safety of rimegepant 75 mg for the acute treatment of migraine in adults with a history of triptan treatment failure. Presented at 2021 American Academy of Neurology Annual Meeting; April 17-22. Abstract P10.004
2. Mullin K, Kudrow D, Croop R, et al. Potential for treatment benefit of small molecule CGRP receptor antagonist plus monoclonal antibody in migraine therapy. Neurology. 2020;00:1-5. doi:10.1212/WNL.0000000000008944.
3. U.S. FDA Accepts Biohaven's Supplemental New Drug Application (sNDA) Of NURTEC™ ODT For The Preventive Treatment Of Migraine. News release. New Haven, CT. Biohaven. Published October 14, 2020. Accessed April 15, 2021. biospace.com/article/releases/u-s-fda-accepts-biohaven-s-supplemental-new-drug-application-snda-of-nurtec-odt-for-the-preventive-treatment-of-migraine
4. Biohaven's NURTEC™ ODT (rimegepant) Receives FDA Approval for the Acute Treatment of Migraine in Adults. News release. Biohaven. February 27, 2020. Accessed April 15, 2021. prnewswire.com/news-releases/biohavens-nurtec-odt-rimegepant-receives-fda-approval-for-the-acute-treatment-of-migraine-in-adults-301013021.html.
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