Rimegepant Explained

Tradename:Nurtec ODT, Vydura
Dailymedid:Rimegepant
Pregnancy Au:B1
Pregnancy Au Comment:[1] [2]
Routes Of Administration:By mouth
Class:Calcitonin gene-related peptide receptor antagonist
Atc Prefix:N02
Atc Suffix:CD06
Legal Au:S4
Legal Au Comment:[3]
Legal Ca:Rx-only
Legal Ca Comment:[4] [5] [6] [7]
Legal Us:Rx-only
Legal Eu:Rx-only
Legal Eu Comment:[8]
Legal Status:Rx-only
Cas Number:1289023-67-1
Pubchem:51049968
Drugbank:DB12457
Chemspiderid:27289072
Unii:997WVV895X
Kegg:D10663
Kegg2:D10662
Chembl:2178422
Synonyms:BHV-3000, BMS-927711
Iupac Name:[(5''S'',6''S'',9''R'')-5-Amino-6-(2,3-difluorophenyl)-6,7,8,9-tetrahydro-5''H''-cyclohepta[''b'']pyridin-9-yl] 4-(2-oxo-3H-imidazo[4,5-''b'']pyridin-1-yl)piperidine-1-carboxylate
C:28
H:28
F:2
N:6
O:3
Smiles:N[C@@H]1c2cccnc2[C@H](OC(=O)N2CCC(n3c(=O)[nH]c4ncccc43)CC2)CC[C@H]1c1cccc(F)c1F
Stdinchi:1S/C28H28F2N6O3/c29-20-6-1-4-17(23(20)30)18-8-9-22(25-19(24(18)31)5-2-12-32-25)39-28(38)35-14-10-16(11-15-35)36-21-7-3-13-33-26(21)34-27(36)37/h1-7,12-13,16,18,22,24H,8-11,14-15,31H2,(H,33,34,37)/t18-,22+,24-/m0/s1
Stdinchikey:KRNAOFGYEFKHPB-ANJVHQHFSA-N

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.[9] It is taken by mouth to dissolve on or under the tongue.[10] It works by blocking CGRP receptors.

In the United States, rimegepant was approved for treating acute migraine in February 2020,[11] and its approval was extended to preventing episodic migraine in June 2021. It is produced and marketed by Pfizer.[12] In March 2021, rimegepant was approved for medical use in the United Arab Emirates and in Israel.[13] [14] It was approved for medical use in Canada in December 2023. In the United Kingdom, rimegepant is approved by NICE for the prophylaxis and treatment of acute migraine in adults.[15]

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.

Mechanism of action

Rimegepant is a small molecule calcitonin gene-related peptide (CGRP) receptor antagonist.[16]

History

Rimegepant was developed by Biohaven Pharmaceuticals, which markets the drug in the United States after receiving FDA approval in February 2020.[17] Approval was based on evidence from one clinical trial of 1,351 subjects with migraine headaches.

Society and culture

Legal status

On 24 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. The applicant for this medicinal product is Biohaven Pharmaceutical Ireland DAC.[18] Rimegepant was approved for medical use in the European Union in April 2022.[19]

Notes and References

  1. Web site: Nurtec ODT . Therapeutic Goods Administration (TGA) . 8 August 2023 . 10 September 2023 . 11 October 2023 . https://web.archive.org/web/20231011034146/https://www.tga.gov.au/resources/auspmd/nurtec-odt . live .
  2. https://www.tga.gov.au/resources/auspar/auspar-nurtec-odt
  3. Web site: Nurtec ODT (Pfizer Australia Pty Ltd) . Therapeutic Goods Administration (TGA) . 22 August 2023 . 10 September 2023 . 11 September 2023 . https://web.archive.org/web/20230911062009/https://www.tga.gov.au/resources/prescription-medicines-registrations/nurtec-odt-pfizer-australia-pty-ltd . live .
  4. Web site: Archived copy . 10 March 2024 . 3 March 2024 . https://web.archive.org/web/20240303042414/https://pdf.hres.ca/dpd_pm/00073578.PDF . live .
  5. Web site: Notice: Multiple additions to the Prescription Drug List (PDL) [2024-02-28] ]. . 28 February 2024 . 2 March 2024 . 2 March 2024 . https://web.archive.org/web/20240302070630/https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/notices-changes/multiple-additions-2024-02-28.html . live .
  6. Web site: Details for: Nurtec ODT . . 1 December 2023 . 3 March 2024 . 3 March 2024 . https://web.archive.org/web/20240303045837/https://dhpp.hpfb-dgpsa.ca/dhpp/resource/103205 . live .
  7. Web site: Summary Basis of Decision for Nurtec ODT . Drug and Health Products Portal . 1 September 2012 . 23 July 2024.
  8. Web site: Vydura EPAR . European Medicines Agency (EMA) . 22 February 2022 . 11 May 2022 . 16 October 2022 . https://web.archive.org/web/20221016031614/https://www.ema.europa.eu/en/medicines/human/EPAR/vydura . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  9. Web site: Drug Trials Snapshots: Nurtec ODT . U.S. Food and Drug Administration (FDA) . 27 February 2020 . 19 March 2020 . 1 October 2020 . https://web.archive.org/web/20201001172300/https://www.fda.gov/drugs/development-approval-process-drugs/drug-trials-snapshots-nurtec-odt . live .
  10. Web site: 19 February 2020. Nurtec ODT - rimegepant sulfate tablet, orally disintegrating. 19 March 2020. DailyMed. 28 November 2020. https://web.archive.org/web/20201128130338/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9ef08e09-1098-35cc-e053-2a95a90a3e1d. live.
  11. Web site: Drug Approval Package: Nurtec ODT . U.S. Food and Drug Administration (FDA) . 26 March 2020 . 16 October 2022 . 27 December 2021 . https://web.archive.org/web/20211227225033/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212728Orig1s000TOC.cfm . live .
  12. Pfizer Completes Acquisition of Biohaven Pharmaceuticals . Pfizer . 3 October 2022 . 16 October 2022 . 5 October 2022 . https://web.archive.org/web/20221005192635/https://www.pfizer.com/news/press-release/press-release-detail/pfizer-completes-acquisition-biohaven-pharmaceuticals . live .
  13. Web site: Biohaven Pharma's Nurtec ODT Approved In Israel For Acute Treatment Of Migraine. 3 June 2021. StreetInsider.com. 3 June 2021. https://web.archive.org/web/20210603094408/https://www.streetinsider.com/Corporate+News/Biohaven+Pharmas+(BHVN)+NURTEC+ODT+Approved+In+Israel+For+Acute+Treatment+Of+Migraine/18106014.html. live.
  14. Biohaven's Nurtec ODT Approved In United Arab Emirates For Acute Treatment Of Migraine. 3 June 2021. Biohaven Pharmaceuticals. 11 March 2021. https://web.archive.org/web/20210311142746/https://www.biohavenpharma.com/investors/news-events/press-releases/03-11-2021-3. live.
  15. Web site: 2023-10-18 . Overview Rimegepant for treating migraine Guidance NICE . 2024-07-26 . www.nice.org.uk.
  16. Diener HC, Charles A, Goadsby PJ, Holle D . New therapeutic approaches for the prevention and treatment of migraine . The Lancet. Neurology . 14 . 10 . 1010–1022 . October 2015 . 26376968 . 10.1016/S1474-4422(15)00198-2 . 26523013 .
  17. Biohaven's Nurtec ODT (rimegepant) Receives FDA Approval for the Acute Treatment of Migraine in Adults . Biohaven Pharmaceuticals Holding Company Ltd. . PR Newswire . 27 February 2020 . 28 February 2020 . 26 July 2021 . https://web.archive.org/web/20210726224218/https://www.prnewswire.com/news-releases/biohavens-nurtec-odt-rimegepant-receives-fda-approval-for-the-acute-treatment-of-migraine-in-adults-301013021.html . live .
  18. Web site: Vydura: Pending EC decision . European Medicines Agency (EMA) . 24 February 2022 . 27 February 2022 . 27 February 2022 . https://web.archive.org/web/20220227042541/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/vydura . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  19. Web site: Vydura Product information . Union Register of medicinal products . 3 March 2023 . 4 March 2023 . https://web.archive.org/web/20230304071349/https://ec.europa.eu/health/documents/community-register/html/h1645.htm . live .

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