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#367 Oral Calcitonin Gene-related Peptide Antagonists: A painfully long name for the acute treatment of migraines

What are the risks and benefits of ubrogepant for the acute treatment of episodic migraines?

Ubrogepant is an oral calcitonin gene-related peptide (CGRP) antagonist approved for the acute treatment of episodic migraines. At 2 hours, ubrogepant is more effective than placebo for freedom from pain (21% versus 13%) or pain relief (61% versus 49%). Ubrogepant is well tolerated; safety in people with co-morbidities is unclear.

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  • Results statistically significant unless stated.  
  • 11 systematic reviews1-11 of the same 2-3 industry-funded randomized controlled trials (RCTs).12-14 Participants with 2-8 migraines/month (with or without aura) given ubrogepant or placebo for acute moderate-severe migraine.
    • Focusing on one systematic review1 of all 3 RCTs (25-100mg) with usable ubrogepant results (3326 participants, 24% on prophylaxis (non-CGRP):12,13
      • Pain free at 2 hours: 21% versus 13% (placebo).
        • No difference between 25, 50 and 100mg doses.
      • Relief at 2 hours (from moderate/severe pain to mild/no pain): 61% versus 49% (placebo).
      • Absence of the most bothersome symptom at 2 hours: 37% versus 28% (placebo).
      • Normal functioning at 2 hours: 42% versus 32% (placebo).
      • Sustained pain relief at 24 hours: 37% versus 22% (placebo).
    • Limitations: Single dose trials, industry funded.
    • Other systematic reviews showed similar.2-11
    • No difference in adverse events.1-3,7 One systematic review3 found more ear, nose and throat-related adverse events but no absolute numbers reported.
  • A one-year, open-label RCT evaluated safety of ubrogepant versus usual care (1230 participants, 31968 doses).15
    • Discontinuation due to adverse events 2-3% with ubrogepant, similar to usual care. No statistical comparison.

  • Ubrogepant (Ubrelvy®) is the only CGRP antagonist approved in Canada for acute migraine treatment.16 Costs ∽$15/dose.17
  • No direct comparison available but triptans appear more effective (30-40% pain free at 2 hours versus 21% [ubrogepant]).1,3,4,11,18
    • Response to ubrogepant independent from response to triptans.19,20
  • Based on 1 RCT, ubrogepant likely effective at preventing headache when taken during prodrome (no moderate-severe headache at 24 hours: 46% versus 29% [placebo]).21
  • Efficacy in chronic migraines,12,13 role with concomitant prophylactic CGRP antagonists,22,23 long-term safety,24,25 safety in people with cardiovascular disease26,27 unclear.

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  • Nicolas Dugré PharmD MSc BCPAC
  • Émélie Braschi MD PhD

1. Yang Y, Chen M, Sun Y, et al. CNS Drugs. 2020 May; 34(5):463-471.

2. Huang T, Xu Y, Chen Y, et al. Brain Behav. 2022 Apr; 12(4):e2542.

3. VanderPluym JH, Halker Singh RB, et al. JAMA. 2021 Jun 15; 325(23):2357-2369.

4. Ha DK, Kim MJ, Han N, et al. Clin Drug Investig. 2021 Feb; 41(2):119-132.

5. Puledda F, Younis S, Huessler EM, et al. Cephalalgia. 2023 Mar; 43(3):3331024231151419.

6. Polavieja P, Belger M, Venkata SK, et al. J Headache Pain. 2022 Jul 6; 23(1):76.

7. Zhang Z, Shu Y, Diao Y, et al. Medicine (Baltimore). 2021 Feb 26; 100(8):e24741.

8. Singh A, Gupta D, Singh A. Neurol India.  2021 Mar-Apr; 69(Supplement):S43-S50.

9. Johnston K, Popoff E, Deighton A, et al. Expert Rev Pharmacoecon Outcomes Res.  2022 Jan; 22(1):155-166.

10. Pak K, Kim J, Lee G, et al. Eur Neurol.  2022; 85(3):195-201.

11. Yang CP, Liang CS, Chang CM, et al. JAMA Netw Open. 2021 Oct 1; 4(10):e2128544.

12. Dodick DW, Lipton RB, Ailani A, et al. N Engl J Med. 2019; 381:2230-2241. 

13. Lipton RB, Dodick DW, Ailani J, et al. JAMA. 2019 Nov 19; 322(19):1887-1898. 

14. Voss T, Lipton RB, Dodick DW, et al. Cephalalgia. 2016 Aug; 36(9):887-98.

15. Ailani J, Lipton RB, Hutchinson S, et al. Headache. 2020 Jan; 60(1):141-152. 

16. AbbVie Corporation. Product monograph : Ubrelvy. November 2022. Accessed September 21,2023.

17. PharmaClik. McKesson Canada. 2024. Accessed February 22, 2024.

18. Ferrari MD, Goadsby PJ, Roon KI, et al. Cephalalgia. 2002 Oct; 22(8):633-58.

19. Blumenfeld AM, Goadsby PJ, Dodick DW, et al. Headache. 2021 Mar; 61(3):422-429. 

20. Lipton RB, Singh RBH, Revicki DA, et al. J Headache Pain. 2022 Apr 25; 23(1):50.

21. Dodick DW, Goadsby PJ, Schwedt TJ, et al. Lancet. 2023; 402:2307-16.

22. Blumenfeld AM, Boinpally R, De Abreu Ferreira R, et al. Headache. 2023 Mar; 63(3):322-332.

23. Jakate A, Blumenfeld AM, Boinpally R, et al. Headache. 2021 Apr; 61(4):642-652.

24. Chiang CC, Arca KN, Dunn RB, et al. Headache. 2021 Apr; 61(4):620-627. 

25. Battini V, Carnovale C, Clementi E, et al. Expert Opin Drug Saf. 2023 Jun 12: 1-8. 

26. Robblee J, Harvey LK. Curr Pain Headache Rep. 2022 Aug; 26(8):647-655.

27. Hutchinson S, Silberstein SD, Blumenfeld AM, et al. Cephalalgia. 2021 Aug; 41(9):979-990. 

Authors do not have any conflicts of interest to declare.