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AboutCurrent Migraine Treatment LimitationsMechanism of ActionEfficacyStudy DesignsAcute TreatmentPreventive TreatmentSafetyDosingResourcesPatient Resources

Currently not reimbursed by the HSE.

Demonstrated efficacy in treating
acute migraine attacks1

In 3 randomised, double-blind, placebo-controlled clinical trials, VYDURA* demonstrated significant improvements vs placebo in treating migraine attacks.1

*The acute treatment trials used either VYDURA (303) or a tablet formulation bioequivalent to VYDURA (301, 302).2

VYDURA demonstrated superiority in freedom from pain and freedom from most bothersome symptom co-primary endpoints vs placebo1Significant improvement in pain relief and ability to get back to normal activities was seen within 60 minutes in patients treated with VYDURA vs placebo3VYDURA provided sustained pain relief from a migraine attack for up to 48 hours1VYDURA was effective in patients with a history of triptan treatment failure5 
  • A pooled, post hoc analysis of the 3 double-blind, placebo-controlled trials (N=3507 subjects) of similar design compared the efficacy of VYDURA 75 mg or a rimegepant 75 mg tablet bioequivalent to placebo for the acute treatment of a migraine attack5
  • Triptan failure was defined as a self-report of a history of discontinuing 1 or more triptans due to inadequate efficacy and/or tolerability5

▼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.

References:VYDURA (rimegepant) Summary of Product Characteristics. European Medicines Agency. Vydura (rimegepant) Assessment Report. 2022. 1-135.Croop R, Goadsby PJ, Stock DA, et al. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. Lancet. 2019;394(10200):737-745. Data on File. [BHV3000-303]. Biohaven Pharmaceuticals. Lipton RB, Blumenfeld AM, Jensen AM, et al. Rimegepant for the acute treatment of migraine: subgroup analyses from 3 phase 3 clinical trials by number of triptans previously tried and failed. Abstract presented at American Headache Society: 2021 Virtual Annual Scientific Meeting (63rd). June 3-6, 2021. Headache. 2021;61(suppl 1):144-145.Data on File. [Lipton AHS 2021 DOF Abstract]. 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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