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AboutCurrent Migraine Treatment LimitationsMechanism of ActionEfficacyStudy DesignsAcute TreatmentPreventive TreatmentSafetyDosingResourcesPatient Resources

Currently not reimbursed by the HSE.

Study 303 assessed the efficacy and safety of VYDURA for acute treatment of migraine1,2

MBS, most bothersome symptom.
*Study 303 is 1 of 3 Phase III trials with VYDURA or a 75 mg rimegepant tablet formulation bioequivalent to VYDURA in acute migraine treatment. For information on Studies 301 and 302, see the SmPC.1,3
Participants who had not had an attack of moderate or severe pain intensity within 45 days of randomisation were instructed to return unused study medication and the eDiary to the study centre and complete all end-of-study procedures.2

Study 305 assessed the efficacy and safety of VYDURA for the prevention of episodic migraine1,4

MMDs, monthly migraine days.
This study evaluated a rimegepant 75 mg tablet formulation bioequivalent to VYDURA.3,4
§78 (21%) VYDURA-treated patients and 95 (26%) placebo-treated patients had a history of chronic migraine, as assessed by the site PI according to the International Classification of Headache Disorders-3 criteria.4
||Permitted rescue medications during the 12-week double-blind treatment phase included triptans, non-steroidal anti-inflammatory drugs, paracetamol up to 1000 mg/day for a maximum of 2 consecutive days (including a fixed combination containing paracetamol 250 mg, aspirin 250 mg, and caffeine 65 mg), baclofen, antiemetics, and muscle relaxants. VYDURA was not permitted as a rescue medication.4
This is the number of patients who were randomised and took at least one dose of VYDURA.5

▼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.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, doubleblind,
placebo-controlled trial. Lancet. 2019;394(10200):737-745.
European Medicines Agency. Vydura (rimegepant) Assessment Report. 2022. 1-135.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, Kudrow D, Smith TR, et al. Safety and tolerability of rimegepant every other day for preventive treatment of migraine plus as-needed for acute treatment of migraine: results from a 52-week, open-label extension study. Abstract presented at the 64th Annual Scientific Meeting of the American Headache Society. June 9-12. Headache. 2022;62(suppl 1):99.

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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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