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Lasmiditan: First Approval

Drugs volume 79, pages 1989–1996 (2019)Cite this article

Abstract

Lasmiditan (REYVOW™; Eli Lilly and Company) is an orally available serotonin (5-HT)1F receptor agonist. In October 2019, the US FDA approved lasmiditan 50 mg and 100 mg tablets for the acute treatment of migraine with or without aura in adults. Approval was based on positive results from two pivotal phase III trials, in which lasmiditan significantly improved the proportions of patients achieving freedom from headache pain and freedom from the most bothersome symptom (photophobia, phonophobia or nausea), relative to placebo, when used to treat a migraine with moderate to severe pain. Lasmiditan is not for use in the preventive treatment of migraine. This article summarizes the milestones in the development of lasmiditan leading to its first approval for the acute treatment of migraine in adults.

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References

  1. Eli Lilly. REYVOW (lasmiditan) tablets, for oral use [controlled substance schedule pending]: US prescribing information. 2019. http://pi.lilly.com/. Accessed 11 Nov 2019.

  2. US Food & Drug Administration (FDA). FDA approves new treatment for patients with migraine [media release]. 11 Oct 2019. http://www.fda.gov.

  3. Moreno-Ajona D, Chan C, Villar-Martínez MD, et al. Targeting CGRP and 5-HT1F receptors for the acute therapy of migraine: a literature review. Headache. 2019;59(Suppl 2):3–19.

    Article  Google Scholar 

  4. Vila-Pueyo M. Targeted 5-HT1F therapies for migraine. Neurotherapeutics. 2018;15(2):291–303.

    CAS  Article  Google Scholar 

  5. Eli Lilly. Lilly’s REYVOW™ (lasmiditan), the first and only medicine in a new class of acute treatment for migraine, receives FDA approval [media release]. 11 Oct 2019. http://www.prnewswire.com.

  6. Eli Lilly. Lilly completes acquisition of CoLucid Pharmaceuticals [media release]. 01 Mar 2017. http://www.lilly.com.

  7. United States Securities and Exchange Commission. Schedule 14D-9 form: solicitation/recommendation statement (CoLucid Pharmaceuticals, Inc.). 2017. http://www.sec.gov/. Accessed 11 Nov 2019.

  8. CoLucid Pharmaceuticals, Ildong Pharmaceutical Co Ltd. CoLucid Pharmaceuticals and ILDONG Pharmaceutical enter into a distribution and supply agreement for lasmiditan, a novel agent for acute migraine [media release]. 22 Oct 2013. http://www.colucid.com.

  9. Nelson DL, Phebus LA, Johnson KW, et al. Preclinical pharmacological profile of the selective 5-HT1F receptor agonist lasmiditan. Cephalalgia. 2010;30(10):1159–69.

    Article  Google Scholar 

  10. Rubio-Beltrán E, Labastida-Ramirez A, Haanes KA, et al. Characterization of binding, functional activity and contractile responses of the selective 5-HT1F receptor agonist lasmiditan. Br J Pharmacol. 2019. https://doi.org/10.1111/bph.14832.

    Article  PubMed  Google Scholar 

  11. Pearlman EM, Doty EG, Dennehy EB, et al. Effects of lasmiditan on driving performance: results of 2 randomized, blinded, crossover simulated driving studies with placebo and active controls (abstract no. IOR06). Headache. 2019;59(Suppl 1):22–3.

    Google Scholar 

  12. Bener A, Dunn EV, Achan NV. Migraine associated with road traffic accidents in the United Arab Emirates. Neurosciences. 2001;6(1):33–7.

    CAS  PubMed  Google Scholar 

  13. Wilbraham D, Tsai M, Case MG. Effects of lasmiditan on cardiovascular parameters in healthy subjects receiving oral doses of propranolol [abstract no. P114]. Headache. 2019;59(Suppl 1):99.

    Google Scholar 

  14. Berg PH, Wilbraham D, Tsai M. Effects of lasmiditan when coadministered with sumatriptan: results of a randomized, double-blind, crossover study in healthy subjects [abstract no. 145]. Headache. 2019;59(Suppl 1):115.

    Google Scholar 

  15. Berg PH, Wilbraham D, Tsai M. Effects of lasmiditan when coadministered with topiramate: results of a parallel, placebo-controlled, fixed-sequence study in healthy subjects [abstract no. P146]. Headache. 2019;59(Suppl 1):116.

    Google Scholar 

  16. Kuca B, Silberstein SD, Wietecha L, et al. Lasmiditan is an effective acute treatment for migraine: a phase 3 randomized study. Neurology. 2018;91(24):e2222–32.

    CAS  Article  Google Scholar 

  17. Goadsby PJ, Wietecha LA, Dennehy EB, et al. Phase 3 randomized, placebo-controlled, double-blind study of lasmiditan for acute treatment of migraine. Brain. 2019;142(7):1894–904.

    Article  Google Scholar 

  18. Ashina M, Vasudeva R, Jin L, et al. Onset of efficacy following oral treatment with lasmiditan for the acute treatment of migraine: integrated results from two randomized double-blind placebo-controlled phase 3 clinical studies. Headache. 2019. https://doi.org/10.1111/head.13636.

    Article  PubMed  Google Scholar 

  19. Doty EG, Krege JH, Jin L, et al. Sustained responses to lasmiditan: results from post hoc analyses of two phase 3 randomized clinical trials for acute treatment of migraine. Cephalalgia. 2019;39(12):1569–76.

    Article  Google Scholar 

  20. Loo LS, Ailani J, Schim J, et al. Efficacy and safety of lasmiditan in patients using concomitant migraine preventive medications: findings from SAMURAI and SPARTAN, two randomized phase 3 trials. J Headache Pain. 2019;20(1):84.

    Article  Google Scholar 

  21. Shapiro RE, Hochstetler HM, Dennehy EB, et al. Lasmiditan for acute treatment of migraine in patients with cardiovascular risk factors: post hoc analysis of pooled results from 2 randomized, double-blind, placebo-controlled, phase 3 trials. J Headache Pain. 2019;20(90):1–10.

    CAS  Google Scholar 

  22. Brandes JL, Klise S, Krege JH, et al. Interim results of a prospective, randomized, open-label, phase 3 study of the long-term safety and efficacy of lasmiditan for acute treatment of migraine (the GLADIATOR study). Cephalalgia. 2019;39(11):1343–57.

    Article  Google Scholar 

  23. Färkkilä M, Diener HC, Géraud G, et al. Efficacy and tolerability of lasmiditan, an oral 5-HT1F receptor agonist, for the acute treatment of migraine: a phase 2 randomised, placebo-controlled, parallel-group, dose-ranging study. Lancet Neurol. 2012;11(5):405–13.

    Article  Google Scholar 

  24. Ferrari MD, Färkkilä M, Reuter U, et al. Acute treatment of migraine with the selective 5-HT1F receptor agonist lasmiditan—a randomised proof-of-concept trial. Cephalalgia. 2010;30(10):1170–8.

    Article  Google Scholar 

  25. Krege JH, Rizzoli PB, Liffick E, et al. Safety findings from phase 3 lasmiditan studies for acute treatment of migraine: results from SAMURAI and SPARTAN. Cephalalgia. 2019;39(8):957–66.

    Article  Google Scholar 

  26. Tepper SJ, Krege JH, Lombard L, et al. Characterization of dizziness after lasmiditan usage: findings from the SAMURAI and SPARTAN acute migraine treatment randomized trials. Headache. 2019;59(7):1052–62.

    Article  Google Scholar 

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    Yvette N. Lamb

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Correspondence to Yvette N. Lamb.

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The preparation of this review was not supported by any external funding.

Conflict of Interest

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the author on the basis of scientific completeness and accuracy. Yvette Lamb is a salaried employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.

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for this AdisInsight Report can be found at https://doi.org/10.6084/m9.figshare.10282130.

This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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Lamb, Y.N. Lasmiditan: First Approval. Drugs 79, 1989–1996 (2019). https://doi.org/10.1007/s40265-019-01225-7

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