Clinical data | |
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Trade names | Qulipta, Aquipta |
Other names | AGN-241689, MK-8031 |
AHFS/Drugs.com | Monograph |
MedlinePlus | a621052 |
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Routes of administration | By mouth |
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Chemical and physical data | |
Formula | C29H23F6N5O3 |
Molar mass | 603.525 g·mol−1 |
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Atogepant, sold under the brand name Qulipta among others, is a medication used to prevent migraines.[4][5] It is a gepant, an orally active calcitonin gene-related peptide receptor antagonist.[4][7]
The most common side effects include nausea (feeling sick), constipation, tiredness, somnolence (sleepiness), decreased appetite, and decreased weight.[5]
Atogepant was approved for medical use in the United States in September 2021,[4][8] and in the European Union in August 2023.[5][9]
Medical Uses
Atogepant is indicated for the preventive treatment of episodic migraine in adults.[4][5]
In the European Union, atogepant (Aquipta) is indicated for prophylaxis (prevention) of migraine in adults who have at least four migraine days per month.[5]
History
The benefits and side effects of atogepant were evaluated in two clinical trials of 1,562 participants with a history of migraine headaches occurring on 4 to 14 days per month.[10] The two trials to show the benefits were designed similarly.[10] Trials 1 and 2 assigned participants to one of several doses of atogepant or placebo daily for three months.[10] Neither the participants nor the health care providers knew which treatment was being given until after the trial was completed.[10] The benefit of atogepant was assessed based on the change from baseline in the number of migraine days per month to the last month of the three-month treatment period, comparing participants in the atogepant and placebo groups.[10] The trials were conducted at over 100 sites in the United States.[10] The safety of atogepant was evaluated in 1,958 participants with migraine who received at least one dose of atogepant; therefore, the number of participants representing efficacy findings may differ from the number of participants representing safety findings due to different pools of study participants analyzed for efficacy and safety.[10]
Research
A study found that atogepant reduced the number of migraine days over twelve weeks.[11]
References
- 1 2 https://www.tga.gov.au/resources/auspmd/aquipta
- ↑ "Summary Basis of Decision for Qulipta". Health Canada. 20 April 2023. Archived from the original on 20 August 2023. Retrieved 20 August 2023.
- ↑ "Details for: Qulipta". Health Canada. 24 March 2023. Retrieved 20 August 2023.
- 1 2 3 4 5 "Qulipta- atogepant tablet". DailyMed. Archived from the original on 1 November 2021. Retrieved 31 October 2021.
- 1 2 3 4 5 6 "Aquipta EPAR". European Medicines Agency. 25 August 2023. Archived from the original on 25 August 2023. Retrieved 25 August 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ "Aquipta Product information". Union Register of medicinal products. 14 August 2023. Archived from the original on 25 August 2023. Retrieved 25 August 2023.
- ↑ Moreno-Ajona D, Pérez-Rodríguez A, Goadsby PJ (June 2020). "Gepants, calcitonin-gene-related peptide receptor antagonists: what could be their role in migraine treatment?". Current Opinion in Neurology. 33 (3): 309–315. doi:10.1097/WCO.0000000000000806. PMID 32251023. S2CID 215408433.
- ↑ "FDA Approves Qulipta (atogepant), the First and Only Oral CGRP Receptor Antagonist Specifically Developed for the Preventive Treatment of Migraine". AbbVie (Press release). 28 September 2021. Archived from the original on 28 September 2021. Retrieved 29 September 2021 – via PR Newswire.
- ↑ "AbbVie Announces European Commission Approval of Aquipta (atogepant) for the Preventive Treatment of Migraine in Adults" (Press release). AbbVie. 17 August 2023. Retrieved 25 August 2023 – via PR Newswire.
- 1 2 3 4 5 6 7 "Drug Trials Snapshots: Qulipta". U.S. Food and Drug Administration. 28 September 2021. Archived from the original on 25 August 2023. Retrieved 10 September 2023. This article incorporates text from this source, which is in the public domain.
- ↑ Ailani J, Lipton RB, Goadsby PJ, Guo H, Miceli R, Severt L, et al. (August 2021). "Atogepant for the Preventive Treatment of Migraine". The New England Journal of Medicine. 385 (8): 695–706. doi:10.1056/NEJMoa2035908. PMID 34407343. S2CID 237216018.
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