The novel serotonin receptor agonist lasmiditan (Eli Lilly) continues to show promise for acute treatment of migraine.
Topline results from a second phase 3 study known as SPARTAN showed that the drug induced a statistically significant improvement in pain relief relative to placebo 2 hours after the first dose, the company announced today.
The study evaluated the safety and efficacy of three doses of lasmiditan administered orally (50 mg, 100 mg, or 200 mg) compared with placebo for the acute treatment of migraine. Study participants had at least moderate migraine disability (as measured by a Migraine Disability Assessment Score greater than or equal to 11) and an average of more than 5 migraine attacks per month at baseline.
Two hours after the first dose of lasmiditan, the percentage of patients who were free of migraine pain was statistically significantly greater than that of placebo recipients in all three dosing groups: 28.6% for 50 mg (P = .003), 31.4% for 100 mg (P < .001), and 38.8% for 200 mg (P < .001) vs 21.3% for placebo.
Statistically significantly more patients taking lasmiditan were also free of migraine-associated “most bothersome pain,” such as nausea, phonophobia, or photophobia, compared with placebo at 2 hours after the first dose: 40.8% with 50 mg (P = .009), 44.2% with 100 mg (P < .001), and 48.7% with 200 mg (P < .001), vs 33.5% with placebo.
The most commonly reported adverse events with lasmiditan were dizziness, paresthesia, somnolence, fatigue, nausea, and lethargy.
“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,” Christi Shaw, president of Lilly Bio-Medicines, said in a news release.
“Lasmiditan has been designed to target receptors associated with migraine without the vasoconstrictor activity associated with some migraine therapies,” added Robert Conley, MD, distinguished Lilly scholar and Lilly global development leader for migraine therapeutics.
“We hope these results are a significant step forward in the development of new acute migraine treatments for the millions of patients in need, including those who may be poorly served by existing therapies or those with cardiovascular disease or risk factors,” he said.
Results from the SPARTAN study are consistent with results from the SAMURAI study, the first phase 3 study evaluating the safety and efficacy of lasmiditan for the acute treatment of migraine.
As previously reported by Medscape Medical News, the SAMURAI study showed that significantly more patients receiving 100 or 200 mg of lasmiditan within 4 hours of a migraine attack had freedom from pain 2 hours after treatment (the primary endpoint) than those who were given matching placebo. They also had significantly less self-reported nausea, phonophobia, or photophobia.
Lilly plans to submit a new drug application for lasmiditan to the US Food and Drug Administration in the second half of 2018.
An ongoing open-label phase 3 study called GLADIATOR is also evaluating the long-term safety of lasmiditan for the acute treatment of migraine.
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