The Senior Medical Director of Eli Lilly and Company spoke to lasmiditan and the clinical impact the investigational therapy could have for patients with acute migraine.
Kraig Kinchen, MD
Eli Lilly recently submitted a new drug application to the FDA for lasmiditan for the acute treatment of migraine with or without aura in adults, which is backed by research from 2 phase 3 single-attack studies (SAMURAI and SPARTAN) that evaluated the safety and efficacy of lasmiditan.
The study results concluded that at 2 hours following the initial dose of lasmiditan, the percentage of subjects with lasmiditan 200 mg (P <.001) who were migraine pain-free was significantly greater than placebo (lasmiditan 200 mg: SAMURAI 32.2%, SPARTAN 38.8%; placebo: SAMURAI 15.3%, SPARTAN 21.3%). Additionally, the second endpoint was also met, with a significantly greater percentage of patients free of their most bothersome symptom, either sensitivity to light, or sensitivity to sound or nausea, compared to placebo at 2 hours post-first dose (lasmiditan 200 mg: SAMURAI 40.7%, SPARTAN 48.7%; placebo: SAMURAI 29.5%, SPARTAN 33.5%).1
To find out more about lasmiditan and the impact this investigational therapy could have for patients with acute migraine, NeurologyLive spoke with Kraig Kinchen, MD, Senior Medical Director, Eli Lilly and Company, in an exclusive interview.
Kraig Kinchen, MD: Lasmiditan is an investigational, oral, centrally-penetrant, selective serotonin 5-HT1F agonist that is structurally and mechanistically distinct from other approved migraine therapies. Lasmiditan selectively targets 5-HT1F receptors, including those expressed in the trigeminal pathway, and has been designed for the acute treatment of migraine without the vasoconstrictor activity associated with some migraine therapies.
Lasmiditan is the only oral drug in development of its kind that selectively targets 5-HT1F receptors, including those expressed in the trigeminal pathway, without the vasoconstrictor activity associated with some migraine therapies. Lasmiditan was developed to address unmet medical needs in patients with migraine, including patients who may be poorly served by existing therapies or those with cardiovascular (CV) disease or risk factors.
Migraine is a complex, disabling disease that affects every person differently, and many patients spend years cycling through different medications to effectively treat their symptoms. Despite a number of approved acute treatment options for migraine, there are still a large number of patients with migraine who are poorly served by currently available therapies, including those with CV disease or risk factors. If approved, lasmiditan could represent the first significant innovation for the acute treatment of migraine in more than 2 decades.
Lasmiditan is the first and only molecule in the “-ditan” class under evaluation for the treatment of migraine in adults. In the first phase 3 study of lasmiditan, the most frequently reported treatment-emergent adverse events included dizziness, fatigue, lethargy, nausea, paresthesia, and somnolence. In November 2018, Eli Lilly and Company announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lasmiditan for the acute treatment of migraine with or without aura in adults.
Lilly has spent the last 25 years researching innovative therapies for migraine, and we are thrilled to be one step closer to potentially providing a new option with lasmiditan that may enable patients impacted by a migraine attack to achieve headache pain freedom and to experience freedom from the associated most bothersome symptom.
Transcript edited for clarity.
1.Wietecha L, Kuca B, Asafu-Adjei J, et al. Phase 3 Studies (SAMURAI, SPARTAN) of Lasmiditan Compared to Placebo for Acute Treatment of Migraine (S50.008). Neurology. 2018;90. http://n.neurology.org/content/90/15_Supplement/S50.008.