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In a randomised, double-blind, placebo-controlled study, treatment with VYDURA* demonstrated a reduction in monthly migraine days (MMDs) at Weeks 9 through 12. Efficacy was sustained for up to 12 months in the open-label extension period.1
Post hoc analysis of an exploratory endpoint. The analysis of this endpoint at Week 1 was not tested in hierarchical order or adjusted for multiplicity. Subjects had ≥1 day of efficacy data in the observation period and ≥1 week in the double-blind treatment phase.3,4
There was a greater reduction in the number of migraine days during the first month of treatment compared to placebo (-2.9 vs -1.7, P<0.0001, nominal P value, and not controlled for multiplicity).2
▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.
* This study evaluated a rimegepant 75 mg tablet formulation bioequivalent to VYDURA.
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PP-UNP-IRL-0176. January 2023