Wikipedia

Rimegepant

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.[8][10] It is taken by mouth to dissolve on or under the tongue.[8] It works by blocking CGRP receptors.[11]

Rimegepant
Clinical data
Trade namesNurtec ODT, Vydura
Other namesBHV-3000, BMS-927711
AHFS/Drugs.comMonograph
MedlinePlusa620031
License data
Pregnancy
category
Routes of
administration		By mouth
Drug classCalcitonin gene-related peptide receptor antagonist
ATC code
Legal status
Legal status
Identifiers
  • [(5S,6S,9R)-5-Amino-6-(2,3-difluorophenyl)-6,7,8,9-tetrahydro-5H-cyclohepta[b]pyridin-9-yl] 4-(2-oxo-3H-imidazo[4,5-b]pyridin-1-yl)piperidine-1-carboxylate
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
CompTox Dashboard (EPA)
Chemical and physical data
FormulaC28H28F2N6O3
Molar mass534.568 g·mol−1
3D model (JSmol)
  • N[C@@H]1c2cccnc2[C@H](OC(=O)N2CCC(n3c(=O)[nH]c4ncccc43)CC2)CC[C@H]1c1cccc(F)c1F
  • InChI=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
  • Key:KRNAOFGYEFKHPB-ANJVHQHFSA-N

In the United States, rimegepant was approved for treating acute migraine in February 2020,[12] and its approval was extended to preventing episodic migraine in June 2021.[8] It is produced and marketed by Pfizer.[13] In March 2021, rimegepant was approved for medical use in the United Arab Emirates and in Israel.[14][15] It was approved for medical use in Canada in December 2023.[4] In the United Kingdom, rimegepant is approved by NICE for the prophylaxis and treatment of acute migraine in adults.[16]

Medical uses

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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.[8][10][9]

Mechanism of action

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Rimegepant is a small molecule calcitonin gene-related peptide (CGRP) receptor antagonist.[11]

History

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Rimegepant was developed by Biohaven Pharmaceuticals, which markets the drug in the United States after receiving FDA approval in February 2020.[12][17] Approval was based on evidence from one clinical trial of 1,351 subjects with migraine headaches.[10]

Society and culture

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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.[18] 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.[9][19]

References

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  1. ^ a b "Nurtec ODT". Therapeutic Goods Administration (TGA). 8 August 2023. Archived from the original on 11 October 2023. Retrieved 10 September 2023.
  2. ^ https://www.tga.gov.au/resources/auspar/auspar-nurtec-odt [bare URL]
  3. ^ "Nurtec ODT (Pfizer Australia Pty Ltd)". Therapeutic Goods Administration (TGA). 22 August 2023. Archived from the original on 11 September 2023. Retrieved 10 September 2023.
  4. ^ a b "Archived copy" (PDF). Archived (PDF) from the original on 3 March 2024. Retrieved 10 March 2024.{{cite web}}: CS1 maint: archived copy as title (link)
  5. ^ "Notice: Multiple additions to the Prescription Drug List (PDL) [2024-02-28]". Health Canada. 28 February 2024. Archived from the original on 2 March 2024. Retrieved 2 March 2024.
  6. ^ "Details for: Nurtec ODT". Health Canada. 1 December 2023. Archived from the original on 3 March 2024. Retrieved 3 March 2024.
  7. ^ "Summary Basis of Decision for Nurtec ODT". Drug and Health Products Portal. 1 September 2012. Retrieved 23 July 2024.
  8. ^ a b c d e "Nurtec ODT - rimegepant sulfate tablet, orally disintegrating". DailyMed. 19 February 2020. Archived from the original on 28 November 2020. Retrieved 19 March 2020.
  9. ^ a b c "Vydura EPAR". European Medicines Agency (EMA). 22 February 2022. Archived from the original on 16 October 2022. Retrieved 11 May 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  10. ^ a b c "Drug Trials Snapshots: Nurtec ODT". U.S. Food and Drug Administration (FDA). 27 February 2020. Archived from the original on 1 October 2020. Retrieved 19 March 2020.   This article incorporates text from this source, which is in the public domain.
  11. ^ a b Diener HC, Charles A, Goadsby PJ, Holle D (October 2015). "New therapeutic approaches for the prevention and treatment of migraine". The Lancet. Neurology. 14 (10): 1010–1022. doi:10.1016/S1474-4422(15)00198-2. PMID 26376968. S2CID 26523013.
  12. ^ a b "Drug Approval Package: Nurtec ODT". U.S. Food and Drug Administration (FDA). 26 March 2020. Archived from the original on 27 December 2021. Retrieved 16 October 2022.
  13. ^ "Pfizer Completes Acquisition of Biohaven Pharmaceuticals". Pfizer (Press release). 3 October 2022. Archived from the original on 5 October 2022. Retrieved 16 October 2022.
  14. ^ "Biohaven Pharma's Nurtec ODT Approved In Israel For Acute Treatment Of Migraine". StreetInsider.com. Archived from the original on 3 June 2021. Retrieved 3 June 2021.
  15. ^ "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.
  16. ^ "Overview | Rimegepant for treating migraine | Guidance | NICE". www.nice.org.uk. 18 October 2023. Retrieved 26 July 2024.
  17. ^ "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.
  18. ^ a b "Vydura: Pending EC decision". European Medicines Agency (EMA). 24 February 2022. Archived from the original on 27 February 2022. Retrieved 27 February 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  19. ^ "Vydura Product information". Union Register of medicinal products. Archived from the original on 4 March 2023. Retrieved 3 March 2023.
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