Chemistry:Rimegepant

From HandWiki

Rimegepant, sold under the brand name Nurtec ODT among others, is a medication used for the acute treatment of migraine with or without aura in adults and the prophylactic/ preventive treatment of episodic migraine in adults.[1][2] It is taken by mouth to dissolve on or under the tongue.[1] It works by blocking CGRP receptors.[3]

In the United States, rimegepant was approved for treating acute migraine in February 2020,[4] and its approval was extended to preventing episodic migraine in June 2021.[1] It is produced and marketed by Pfizer.[5] In March 2021, rimegepant was approved for medical use in the United Arab Emirates and in Israel.[6][7] It was approved for medical use in Canada in December 2023.[8] In the United Kingdom, rimegepant is approved by NICE for the prophylaxis and treatment of acute migraine in adults.[9] In 2023, it was the 206th most commonly prescribed medication in the United States, with more than 2 million prescriptions[10][11] .

Medical uses

Rimegepant is indicated for the treatment of acute migraine with or without aura in adults and for the preventative treatment of episodic migraine in adults.[1][2][12]

Mechanism of action

Rimegepant is a small molecule calcitonin gene-related peptide (CGRP) receptor antagonist.[3]

History

Rimegepant was developed by Biohaven Pharmaceuticals, which markets the drug in the United States after receiving FDA approval in February 2020.[4][13] Approval was based on evidence from one clinical trial of 1,351 subjects with migraine headaches.[2]

Society and culture

In February 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Vydura, intended for the prophylaxis and acute treatment of migraine.[14] The applicant for this medicinal product is Biohaven Pharmaceutical Ireland DAC.[14] Rimegepant was approved for medical use in the European Union in April 2022.[12][15]

Economics

Pfizer reported revenue of US$928 million for Nurtec ODT/Vydura in 2023.[16]

Marketing

American singer, songwriter and actress Lady Gaga is featured in advertisements for rimegepant, under the Nurtec ODT brand. Her involvement sparked criticism of the role of celebrities in pharmaceutical endorsements. [17]

References

  1. ↑ 1.0 1.1 1.2 1.3 "Nurtec ODT - rimegepant sulfate tablet, orally disintegrating". 19 February 2020. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9ef08e09-1098-35cc-e053-2a95a90a3e1d. 
  2. ↑ 2.0 2.1 2.2 "Drug Trials Snapshots: Nurtec ODT". 27 February 2020. https://www.fda.gov/drugs/development-approval-process-drugs/drug-trials-snapshots-nurtec-odt.  Public Domain This article incorporates text from this source, which is in the public domain.
  3. ↑ 3.0 3.1 "New therapeutic approaches for the prevention and treatment of migraine". The Lancet. Neurology 14 (10): 1010–1022. October 2015. doi:10.1016/S1474-4422(15)00198-2. PMID 26376968. 
  4. ↑ 4.0 4.1 "Drug Approval Package: Nurtec ODT". 26 March 2020. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212728Orig1s000TOC.cfm. 
  5. ↑ "Pfizer Completes Acquisition of Biohaven Pharmaceuticals". Pfizer (Press release). 3 October 2022. Archived from the original on 5 October 2022. Retrieved 16 October 2022.
  6. ↑ "Biohaven Pharma's Nurtec ODT Approved In Israel For Acute Treatment Of Migraine". https://www.streetinsider.com/Corporate+News/Biohaven+Pharmas+%28BHVN%29+NURTEC+ODT+Approved+In+Israel+For+Acute+Treatment+Of+Migraine/18106014.html. 
  7. ↑ "Biohaven's Nurtec ODT Approved In United Arab Emirates For Acute Treatment Of Migraine". Biohaven Pharmaceuticals (Press release). Archived from the original on 11 March 2021. Retrieved 3 June 2021.
  8. ↑ Cite error: Invalid <ref> tag; no text was provided for refs named Nurtec ODT Monograph CA
  9. ↑ "Overview | Rimegepant for treating migraine | Guidance | NICE". 2023-10-18. https://www.nice.org.uk/guidance/TA919. 
  10. ↑ "The Top 300 of 2023". https://clincalc.com/DrugStats/Top300Drugs.aspx. 
  11. ↑ "Rimegepant - Drug Usage Statistics, United States, 2014 - 2025". https://clincalc.com/DrugStats/Drugs/Rimegepant. 
  12. ↑ 12.0 12.1 Cite error: Invalid <ref> tag; no text was provided for refs named Vydura EPAR
  13. ↑ "Biohaven's Nurtec ODT (rimegepant) Receives FDA Approval for the Acute Treatment of Migraine in Adults" (Press release). Biohaven Pharmaceuticals Holding Company Ltd. 27 February 2020. Archived from the original on 26 July 2021. Retrieved 28 February 2020 – via PR Newswire.
  14. ↑ 14.0 14.1 "Vydura: Pending EC decision". 24 February 2022. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/vydura.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  15. ↑ "Vydura Product information". https://ec.europa.eu/health/documents/community-register/html/h1645.htm. 
  16. ↑ "Pfizer's year in review". 31 December 2023. https://www.pfizer.com/sites/default/files/investors/financial_reports/annual_reports/2023/. 
  17. ↑ "Lady Gaga raises eyebrows over paid partnership with Pfizer migraine drug" (in en). 2023-06-15. https://www.the-independent.com/arts-entertainment/music/news/lady-gaga-pfzier-migrane-drug-ad-b2357922.html. 



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