Indianapolis-based Eli Lilly and Co. (NYSE: LLY) says its second Phase 3 study of an oral migraine treatment has yielded positive results. Lilly says as a result of the positive outcome for lasmiditan, the company plans to submit a New Drug Application with the U.S. Food and Drug Administration in the second half of 2018.
Lilly says the treatment met its primary endpoint in the SPARTAN study, which showed that a greater percentage of patients treated with lasmiditan were migraine pain-free compared to placebo after two hours of taking the first dose. The drug also met is secondary endpoint, which showed that a "statistically significantly greater percentage" of patients were free of their most bothersome symptoms, such as nausea and sensitivity to sound or light.
"Lasmiditan represents the first significant innovation in the acute treatment of migraine in more than 20 years, and could provide a much-needed new treatment option for the 36 million Americans living with migraine," said Christi Shaw, president of Lilly Bio-Medicines. "We are thrilled with these topline lasmiditan results, which add to more than 25 years of Lilly’s research and development of migraine therapies."
The company plans to present data from both studies at scientific meetings and submit results to peer-reviewed journals over the next year. The company has already begun another Phase 3 study, known as GLADIATOR, to evaluate the long-term safety of the drug for the acute treatment of migraine.
The treatment was originally discovered by Lilly in 2005 and later sold the rights to lasmiditan to Massachusetts-based CoLucid Pharmaceuticals Inc, which continued to develop the drug. Lilly recently-completed a $960 million acquisition of CoLucid, a deal which was profiled by Inside INdiana Business Reporter Kylie Veleta in our Life Sciences INdiana e-newsletter.