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atogepant (Qulipta)
Indications:
- prevention of migraine
- reduces mean monthly migraine days [5]
- chronic migraine
Contraindications:
- renal insufficiency, hepatic insufficiency, pregnancy, lactation may be issues
Dosage:
- once-daily oral dose of 10 mg, 30 mg, or 60 mg
* atogepant 30 mg twice a day & 60 mg once a day reduce mean monthly migraine days
* 1.5-1.7 fewer migraine days per month than with placebo
* placebo effect less than, but > 1/2 the effect of atogepant
* see clinical trials below
Adverse effects:
- constipation 7-10%
- nausea 4-6%
- fatigue
Mechanism of action:
- calcitonin gene-related peptide receptor antagonist (gepant)
Clinical trials:
- PROGRESS trial
- baseline: 19 monthly migraine days
- with atogepant: 12 monthly migraine days
- with placebo: 14 monthly migraine days [3]
- ELEVATE trial
- with atogepant: 4.2 fewer migrane days in 12 weeks
- with placebo: 1.9 fewer migrane days in 12 weeks [4]
General
gepant
Database Correlations
PUBCHEM cid=72163100
References
- George J
Novel Migraine Prevention Drug Wins FDA Nod.
Atogepant approval reflects "broader shift" in managing migraine.
MedPage Today September 29, 2021
https://www.medpagetoday.com/neurology/migraines/94759
- Greb E
FDA Okays New Oral CGRP Antagonist for Migraine Prevention.
Medscape. September 29, 2021
https://www.medscape.com/viewarticle/959919
- Pozo-Rosich P, Ailani J, Ashina M, et al.
Atogepant for the preventive treatment of chronic migraine (PROGRESS):
a randomised, double-blind, placebo-controlled, phase 3 trial.
Lancet. 2023 Jul 26:S0140-6736(23)01049-8
PMID: 37516125
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)01049-8/fulltext
- Tassorelli C, Nagy K, Pozo-Rosich P, et al.
Safety and efficacy of atogepant for the preventive treatment of episodic migraine
in adults for whom conventional oral preventive treatments have failed (ELEVATE):
a randomised, placebo-controlled, phase 3b trial.
Lancet Neurol. 2024 Feb 13:S1474-4422(24)00025-5
PMID: 38364831
- Goadsby PJ, Friedman DI, Holle-Lee D, et al.
Efficacy of Atogepant in Chronic Migraine With and Without Acute Medication Overuse
in the Randomized, Double-Blind, Phase 3 PROGRESS Trial.
Neurology. 2024 Jul 23;103(2):e209584.
PMID: 38924724 PMCID: PMC11254449