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REVIEW

Profile of Lasmiditan in the Acute Treatment of Migraine in Adults: Design, Development, and Place in Therapy

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Pages 1979-1993 | Received 06 Apr 2023, Accepted 26 Jun 2023, Published online: 03 Jul 2023

References

  • Neurological Disorders Collaborator Group. Global, regional, and national burden of neurological disorders during 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Neurol. 2017;16(11):877–897. doi:10.1016/S1474-4422(17)30299-5
  • Burch R, Rizzoli P, Loder E. The prevalence and impact of migraine and severe headache in the United States: updated age, sex, and socioeconomic-specific estimates from government health surveys. Headache. 2021;61(1):60–68. doi:10.1111/head.14024
  • Headache Classification Committee of the International Headache Society (IHS). The international classification of headache disorders, 3rd edition. Cephalalgia. 2018;38(1):1–211. doi:10.1177/0333102417738202
  • GlaxoSmithKline. IMITREX highlights of prescribing information. Available from: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Imitrex_Tablets/pdf/IMITREX-TABLETS-PI-PIL.PDF. Accessed September 6, 2023.
  • Charles A. Vasodilation out of the picture as a cause of migraine headache. Lancet Neurol. 2013;12(5):419–420. doi:10.1016/S1474-4422(13)70051-6
  • Amin FM, Asghar MS, Hougaard A, et al. Magnetic resonance angiography of intracranial and extracranial arteries in patients with spontaneous migraine without aura: a cross-sectional study. Lancet Neurol. 2013;12(5):454–461. doi:10.1016/S1474-4422(13)70067-X
  • Edvinsson L, Haanes KA, Warfvinge K. Does inflammation have a role in migraine? Nat Rev Neurol. 2019;15(8):483–490. doi:10.1038/s41582-019-0216-y
  • Dodick DW. A phase-by-phase review of migraine pathophysiology. Headache. 2018;58(Suppl 1):4–16. doi:10.1111/head.13300
  • Borsook D, Maleki N, Becerra L, McEwen B. Understanding migraine through the lens of maladaptive stress responses: a model disease of allostatic load. Neuron. 2012;73(2):219–234. doi:10.1016/j.neuron.2012.01.001
  • Dodick DW, Shewale AS, Lipton RB, et al. Migraine patients with cardiovascular disease and contraindications: an analysis of real-world claims data. J Prim Care Community Health. 2020;11:2150132720963680. doi:10.1177/2150132720963680
  • Reyvow. Lasmiditan prescribing info. Available from: https://www.reyvow.com/hcp/savings-support?gclid=EAIaIQobChMIsvCqkujq_QIVxvbjBx13mwAGEAAYASAAEgJQW_D_BwE. Accessed September 6, 2023.
  • Nelson DL, Phebus LA, Johnson KW, et al. Preclinical pharmacological profile of the selective 5-HT1F receptor agonist lasmiditan. Cephalalgia. 2010;30(10):1159–1169. doi:10.1177/0333102410370873
  • Kovalchin J, Ghiglieri A, Zanelli E, Ings R, Mathers T. Lasmiditan acts specifically on the 5-HT1F receptor in the central nervous system. Cephalalgia. 2016;36(1 Suppl):103. doi:10.1177/0333102415584311
  • Clemow DB, Johnson KW, Hochstetler HM, Ossipov MH, Hake AM, Blumenfeld AM. Lasmiditan mechanism of action - review of a selective 5-HT(1F) agonist. J Headache Pain. 2020;21(1):71. doi:10.1186/s10194-020-01132-3
  • Adham N, Kao HT, Schecter LE, et al. Cloning of another human serotonin receptor (5-HT1F): a fifth 5-HT1 receptor subtype coupled to the inhibition of adenylate cyclase. Proc Natl Acad Sci USA. 1993;90(2):408–412. doi:10.1073/pnas.90.2.408
  • Castro ME, Pascual J, Romon T, Del Arco C, Del Olmo E, Pazos A. Differential distribution of [3H]sumatriptan binding sites (5-HT1B, 5-HT1D and 5-HT1F receptors) in human brain: focus on brainstem and spinal cord. Neuropharmacology. 1997;36(4–5):535–542. doi:10.1016/s0028-3908(97)00061-0
  • Bouchelet I, Cohen Z, Case B, Seguela P, Hamel E. Differential expression of sumatriptan-sensitive 5-hydroxytryptamine receptors in human trigeminal ganglia and cerebral blood vessels. Mol Pharmacol. 1996;50(2):219–223.
  • Cohen Z, Bouchelet I, Olivier A, et al. Multiple microvascular and astroglial 5-hydroxytryptamine receptor subtypes in human brain: molecular and pharmacologic characterization. J Cereb Blood Flow Metab. 1999;19(8):908–917. doi:10.1097/00004647-199908000-00010
  • Bouchelet I, Case B, Olivier A, Hamel E. No contractile effect for 5-HT1D and 5-HT1F receptor agonists in human and bovine cerebral arteries: similarity with human coronary artery. Br J Pharmacol. 2000;129(3):501–508. doi:10.1038/sj.bjp.0703081
  • Wilbraham D, Berg PH, Tsai M, et al. Abuse potential of lasmiditan: a phase 1 randomized, placebo- and alprazolam-controlled crossover study. J Clin Pharmacol. 2020;60(4):495–504. doi:10.1002/jcph.1543
  • Ferrari MD, Farkkila 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):1170–1178. doi:10.1177/0333102410375512
  • Farkkila M, Diener HC, Geraud G, et al. Efficacy and tolerability of lasmiditan, an oral 5-HT(1F) receptor agonist, for the acute treatment of migraine: a phase 2 randomised, placebo-controlled, parallel-group, dose-ranging study. Lancet Neurol. 2012;11(5):405–413. doi:10.1016/S1474-4422(12)70047-9
  • 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–e2232. doi:10.1212/WNL.0000000000006641
  • 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):1894–1904. doi:10.1093/brain/awz134
  • Ashina M, Reuter U, Smith T, et al. Randomized, controlled trial of lasmiditan over four migraine attacks: findings from the CENTURION study. Cephalalgia. 2021;41(3):294–304. doi:10.1177/0333102421989232
  • Sakai F, Takeshima T, Homma G, Tanji Y, Katagiri H, Komori M. Phase 2 randomized placebo-controlled study of lasmiditan for the acute treatment of migraine in Japanese patients. Headache. 2021;61(5):755–765. doi:10.1111/head.14122
  • Takeshima T, Komori M, Tanji Y, Ozeki A, Tatsuoka Y. Efficacy of lasmiditan across patient and migraine characteristics in Japanese patients with migraine: a secondary analysis of the MONONOFU trial. Adv Ther. 2022;39(11):5274–5288. doi:10.1007/s12325-022-02304-0
  • 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):1343–1357. doi:10.1177/0333102419864132
  • Lipton RB, Lombard L, Ruff DD, et al. Trajectory of migraine-related disability following long-term treatment with lasmiditan: results of the GLADIATOR study. J Headache Pain. 2020;21(1):20. doi:10.1186/s10194-020-01088-4
  • Brandes JL, Klise S, Krege JH, et al. Long-term safety and efficacy of lasmiditan for acute treatment of migraine: final results of the GLADIATOR study. Cephalalgia Rep. 2020;3:251581632095817. doi:10.1177/2515816320958176
  • 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 2 randomized double-blind placebo-controlled phase 3 clinical studies. Headache. 2019;59(10):1788–1801. doi:10.1111/head.13636
  • Doty EG, Krege JH, Jin L, Raskin J, Halker Singh RB, Kalidas K. 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):1569–1576. doi:10.1177/0333102419859313
  • Tepper SJ, Vasudeva R, Krege JH, et al. Evaluation of 2-hour post-dose efficacy of lasmiditan for the acute treatment of difficult-to-treat migraine attacks. Headache. 2020;60(8):1601–1615. doi:10.1111/head.13897
  • Peres MFP, Vasudeva R, Baygani SK, Dennehy EB, Vincent M, Friedman DI. Lasmiditan efficacy in migraine attacks with mild vs. moderate or severe pain. Curr Med Res Opin. 2021;37(6):1031–1038. doi:10.1080/03007995.2021.1903846
  • MacGregor EA, Komori M, Krege JH, et al. Efficacy of lasmiditan for the acute treatment of perimenstrual migraine. Cephalalgia. 2022;42(14):1467–1475. doi:10.1177/03331024221118929
  • Loo LS, Plato BM, Turner IM, et al. Effect of a rescue or recurrence dose of lasmiditan on efficacy and safety in the acute treatment of migraine: findings from the phase 3 trials (SAMURAI and SPARTAN). BMC Neurol. 2019;19(1):191. doi:10.1186/s12883-019-1420-5
  • Clemow DB, Hochstetler HM, Dong Y, Hauck P, Peres MFP, Ailani J. Effect of a change in lasmiditan dose on efficacy and safety in patients with migraine. Postgrad Med. 2021;133(4):449–459. doi:10.1080/00325481.2020.1860619
  • Knievel K, Buchanan AS, Lombard L, et al. Lasmiditan for the acute treatment of migraine: subgroup analyses by prior response to triptans. Cephalalgia. 2020;40(1):19–27. doi:10.1177/0333102419889350
  • Reuter U, Krege JH, Lombard L, et al. Lasmiditan efficacy in the acute treatment of migraine was independent of prior response to triptans: findings from the CENTURION study. Cephalalgia. 2022;42(1):20–30. doi:10.1177/03331024211048507
  • 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):957–966. doi:10.1177/0333102419855080
  • Tassorelli C, Bragg S, Krege JH, et al. Safety findings from CENTURION, a phase 3 consistency study of lasmiditan for the acute treatment of migraine. J Headache Pain. 2021;22(1):132. doi:10.1186/s10194-021-01343-2
  • Doty EG, Hauck PM, Krege JH, et al. The association between the occurrence of common treatment-emergent adverse events and efficacy outcomes after lasmiditan treatment of a single migraine attack: secondary analyses from four pooled randomized clinical trials. CNS Drugs. 2022;36(7):771–783. doi:10.1007/s40263-022-00928-y
  • 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):1052–1062. doi:10.1111/head.13544
  • 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(1):90. doi:10.1186/s10194-019-1044-6
  • Martin VT, Ahmed Z, Hochstetler HM, et al. Tolerability and safety of lasmiditan treatment in elderly patients with migraine: post hoc analyses from randomized studies. Clin Ther. 2021;43(6):1066–1078. doi:10.1016/j.clinthera.2021.04.004
  • Pearlman EM, Wilbraham D, Dennehy EB, et al. Effects of lasmiditan on simulated driving performance: results of two randomized, blinded, crossover studies with placebo and active controls. Hum Psychopharmacol. 2020;35(5):e2732. doi:10.1002/hup.2732
  • Hou M, Xing H, Li C, et al. Short-term efficacy and safety of lasmiditan, a novel 5-HT(1F) receptor agonist, for the acute treatment of migraine: a systematic review and meta-analysis. J Headache Pain. 2020;21(1):66. doi:10.1186/s10194-020-01138-x
  • Maiti R, Mishra A, Puliappadamb HM, Jena M, Srinivasan A. Efficacy and safety of lasmiditan for acute treatment of migraine in adults: a meta-analysis. J Clin Pharmacol. 2021;61(12):1534–1544. doi:10.1002/jcph.1962
  • VanderPluym JH, Halker Singh RB, Urtecho M, et al. Acute treatments for episodic migraine in adults: a systematic review and meta-analysis. JAMA. 2021;325(23):2357–2369. doi:10.1001/jama.2021.7939
  • Yang Y, Sun Y, Gao B, Wang Z, Chen Z, Wang Z. Lasmiditan for acute treatment of migraine in adults: a systematic review and meta-analysis of randomized controlled trials. CNS Drugs. 2020;34(10):1015–1024. doi:10.1007/s40263-020-00753-1
  • Zhu H, Tang Y, Zhou T, Song J. The efficacy of lasmiditan for the treatment of migraine: a meta-analysis of randomized controlled studies. Clin Neuropharmacol. 2020;43(6):191–195. doi:10.1097/WNF.0000000000000417
  • Gu P, Chen C, Wu Q, et al. The effect and safety of 5-HT(1F) receptor agonist lasmiditan on migraine: a systematic review and meta-analysis. Biomed Res Int. 2021;2021:6663591. doi:10.1155/2021/6663591
  • Yang CP, Liang CS, Chang CM, et al. Comparison of new pharmacologic agents with triptans for treatment of migraine: a systematic review and meta-analysis. JAMA Netw Open. 2021;4(10):e2128544. doi:10.1001/jamanetworkopen.2021.28544
  • Polavieja P, Belger M, Venkata SK, Wilhelm S, Johansson E. Relative efficacy of lasmiditan versus rimegepant and ubrogepant as acute treatments for migraine: network meta-analysis findings. J Headache Pain. 2022;23(1):76. doi:10.1186/s10194-022-01440-w
  • GoodRx. Reyvow. Available from: https://www.goodrx.com/reyvow/medicare-coverage#:~:text=In%20general%2C%20Medicare%20prescription%20drug%20plans%20%28Part%20D%29,may%20be%20covered%20under%20Medical%20Insurance%20%28Part%20B%29. Accessed May 6, 2023.