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AboutCurrent Migraine Treatment LimitationsMechanism of ActionEfficacyStudy DesignsAcute TreatmentPreventive TreatmentSafetyDosingResourcesPatient Resources

Currently not reimbursed by the HSE.

Demonstrated efficacy in preventing
migraine attacks1

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 

VYDURA* Significantly Reduces Monthly Migraine Days (MMDs)2Reduction in Migraine Frequency Within the First Week and First Month of Treatment With VYDURA*2,3

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 

VYDURA* demonstrated long-term efficacy for preventing monthly migraine days (MMDs)1
  • Efficacy was sustained for up to an additional 12 months during the open-label study extension in which patients received VYDURA1*
  • In these patients, the overall mean reduction from baseline in the number of MMDs averaged over the 16-month treatment period was 6.2 days1

▼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.

References:VYDURA (rimegepant) Summary of Product Characteristics.Croop R, Lipton RB, Kudrow D, et al. Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Lancet. 2021;397(10268):51-60.Lipton, RB, Croop R, Jensen C. et al. Rapid decrease in migraine days with rimegepant: results from a post hoc analysis of a phase 2/3, randomized, double-blind, placebo-controlled trial. Abstract presented at American Headache Society: 2021 Virtual Annual Scientific Meeting (63rd). June 3-6, 2021. Headache. 2021;61(suppl1):138-139.Data on File. [AHS 2021]. Biohaven Pharmaceuticals.
Efficacy

Legal Category: S1B
Further information is available upon request

PP-NNT-IRL-0017. June 2023

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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PP-UNP-IRL-0733. March 2024
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