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EU approves Vydura for migraine.- Pfizer + Biohaven Pharma

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Published:28th Apr 2022

Pfizer and Biohaven Pharmaceutical announced that the European Commission has granted marketing authorization for Vydura (rimegepant), a calcitonin gene-related peptide (CGRP) receptor antagonist for both the acute treatment of migraine with or without aura, and prophylaxis of episodic migraine in adults who have at least four migraine attacks per month.

Vydura, an orally disintegrating tablet, is the first medicine approved for both acute and prophylactic treatment of migraine in the European Union.

Results from the Phase III study published in Lancet demonstrated that a single dose of rimegepant provided superior pain reduction and associated symptoms of migraine at two hours compared to placebo. The prevention study, also published in Lancet, demonstrated that rimegepant taken every other day provided superior reduction in the number of days per month with migraine in Weeks 9 –12 of the 12-week treatment period compared to placebo, that was maintained with continued dosing during the 12-month open-label extension period.

The most frequent adverse event in clinical trials with Vydura was nausea, occurring in 3% of patients compared to 1% with placebo, while hypersensitivity reactions including rash occurred in less than 1% of patients. Less than 2% of patients discontinued from Vydura due to adverse events. Vydura does not have addiction potential and was not associated with medication overuse headache or rebound headache in clinical trials, although overuse of any type of medicinal products for headache can make them worse.

See-"Oral rimegepant for preventive treatment of migraine: a phase II/III, randomised, double-blind, placebo-controlled trial". The Lancet. Vol. 397 No. 10268, p51–60, Published: December 15, 2020 Robert Croop,Richard B Lipton,David Kudrow,David A Stock,Lisa Kamen,Charles M Conwayand others.

Condition: Migraine/Headache
Type: drug

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