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AboutAboutCurrent Treatment LandscapeMechanism Of Action (MOA)DosingDosingRecommended dosing scheduleEfficacy & Safety ProfileEfficacy & SafetyAcute Clinical EfficacyPrevention Clinical EfficacySafety and Tolerability ProfileCHALLENGE-MIGSupporting ResourcesSupport & ResourcesMaterialsVideosOnline Learning

Click here for Vydura® (rimegepant) UK Prescribing Information. Adverse event reporting information can be found at the bottom of the page.

CHALLENGE-MIGA head-to-head study comparing galcanezumab with rimegepant for the preventive treatment of episodic migraine. A double-blind, double-dummy, phase IV randomised controlled trial.1

VYDURA: precautions and contraindications

Rimegepant’s safety profile has shown consistency so far, with results up to one year1,2
Prevention Clinical Efficacy
Discover VYDURA’s efficacy vs placebo in preventing migrainePrevention Clinical EfficacyLoading
Resources and Support
Download a PDF outlining an overview of the CHALLENGE-MIG Study which compares galcanezumab vs Vydura for prevention of episodic migraine Resources and supportLoadingProtocol-specified acute medications allowed for migraine headache treatment (paracetamol; nonsteroidal anti-inflammatory drugs; triptans; ergotamine and derivatives; aspirin, caffeine and paracetamol combination; or combinations thereof), as needed, were permitted during all study periods. Gepants, including rimegepant, were not allowed to be used for acute treatment of migraine.

*The primary estimand of interest was the overall mean monthly 50% response rate across the 3-month double-blind period under the treatment condition (galcanezumab or rimegepant), regardless of the initiation of new preventive migraine medication (protocol violation), the use of acute medication to treat a migraine headache, and the discontinuation of treatment for any reason.
The study was designed to assess whether galcanezumab was superior to rimegepant for the prevention of migraine in patients with episodic migraine (conducted between December 2021 and May 2023 at 75 sites in the USA)1
Galcanezumab did not demonstrate superiority to rimegepant for the prevention of episodic migraine1
Vydura demonstrated similar efficacy to galcanezumab for the prevention of episodic migraine1
 At baseline, participants averaged 8.4 migraine headache days per month. A migraine headache day was defined as a calendar day on which a migraine headache or probable migraine headache occurred.1

~100% treatment compliance with every-other-day dosing was seen in this study across both treatment arms

In accordance with the prespecified multiple testing procedure, the key secondary endpoints could not be considered statistically significant because the primary endpoint was not met.1

Vydura is the only CGRP receptor antagonist to be compared with an injectable CGRP monoclonal antibody (galcanezumab) in a head-to-head clinical trial1

Adverse event rates were similar between galcanezumab and rimegepant treatment arms. There were no clinically meaningful differences between study intervention groups in vital signs or laboratory parameters1

AE, adverse event; EOD, every other day; ODT, orally disintegrating tablet; OR, odds ratio; SAE, serious adverse event; SC, subcutaneous; TEAE, treatment-emergent adverse event. *Participants received SC galcanezumab 120 mg and placebo ODT.1 †Participants received 75 mg rimegepant ODT and SC placebo injection.1

Explore morePrevious pageLearn more about the safety & tolerability data for VYDURA in acute treatment and preventative treatment Safety & Tolerability Profile Next page

Download materials and videos to help support your management of migraine patients with VYDURA
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References:

  1. Schwedt TJ, et al. Neurol Ther 2024;13:85–105
PP-NNT-GBR-3041. May 2025

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