Eli Lilly and Company announced that lasmiditan, an investigational, oral, first-in-class molecule for the acute treatment of migraine, met its primary endpoint in SPARTAN, a second Phase 3 study. At two hours following the first dose, a greater percentage of patients treated with lasmiditan were migraine pain-free compared to placebo. These results were statistically significant across all three studied doses (50 mg, 100 mg and 200 mg).
Lasmiditan also met the key secondary endpoint for SPARTAN across all three studied doses, with a statistically significantly greater percentage of patients free of their most bothersome symptom (MBS) compared with placebo at two hours following the first dose. In this study, patients chose their MBS from nausea, sensitivity to sound or sensitivity to 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 most commonly-reported adverse events after lasmiditan dosing were dizziness, paresthesia, somnolence, fatigue, nausea and lethargy.
These findings are consistent with SAMURAI, the first pivotal Phase 3 study evaluating the safety and efficacy of lasmiditan for the acute treatment of migraine. In this study, lasmiditan met both the primary and key secondary endpoints with statistical significance. Results from SAMURAI were presented at the American Headache Society (AHS) annual meeting in June.
Lilly plans to submit a New Drug Application for lasmiditan to the U.S. Food and Drug Administration (FDA) in the second half of 2018.
At two hours following the first dose of lasmiditan, the percentage of patients who were migraine pain-free was statistically significantly greater compared to placebo in all dosing groups: 28.6 percent for 50 mg (p=0.003); 31.4 percent for 100 mg (p<0.001); 38.8 percent for 200 mg (p<0.001) and 21.3 percent for placebo.
Statistically significantly more patients treated with lasmiditan were also free of their migraine-associated MBS compared to placebo at two hours following the first dose: 40.8 percent for 50 mg (p=0.009); 44.2 percent for 100 mg (p<0.001); 48.7 percent for 200 mg (p<0.001) and 33.5 percent for placebo.
Lasmiditan also demonstrated statistically significant improvements compared to placebo in additional secondary endpoints, including migraine pain relief and migraine disability.
Lilly will present detailed data from both studies at scientific meetings and submit the results to peer-reviewed journals within the next year. An open-label Phase 3 study—GLADIATOR—is also underway evaluating the long-term safety of lasmiditan for the acute treatment of migraine.
Migraine is a disabling neurological disease characterized by recurrent episodes of severe headache accompanied by other symptoms including nausea, vomiting, sensitivity to light and sound, and changes in vision. More than 36 million Americans have migraine, with three times more women affected by migraine compared to men. According to the Migraine Research Foundation, healthcare and lost productivity costs associated with migraine are estimated to be as high as $36 billion annually in the U.S., yet it remains under-recognized and under-treated.