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 2021 American Academy of Neurology (AAN) Annual Meeting, April 17-22.
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.
Mullin previously published data in January 2020 that explored the use of rimegepant in patients with refractory migraine. Among the 2 patients included in the cohort who experienced suboptimal response to medication, concomitant use of rimegepant and erenumab (Aimovig; Amgen) was shown to effectively treat this patient group.2
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 supplemental new drug application (sNDA) for Rimegepant for the prevention of migraine had been accepted by the FDA, with a planned Prescription Drug User Fee Act (PDUFA) action date set for the second quarter of 2021.3
The CGRP tablet was originally approved in a 75-mg dose for the acute treatment of migraine in February 2020, marking the first approval for Biohaven.4 If approved for this second indication, rimegepant would be the first and only GCRP-targeting therapy with indications for both preventive and acute treatment of migraine.
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