Compared with placebo, lasmiditan reduced migraine pain and symptoms after 2 hours for most patients with at least moderate disability, according to findings presented at PAINWeek.
“Lasmiditan is the only oral drug of its kind in development that selectively targets [serotonin-1F] receptors, including those expressed in the trigeminal pathway,” Kraig Kinchen, MD, senior medical director, migraine and related therapeutics, Eli Lilly and Company, told Healio Family Medicine in an interview. “[It] has been designed for the acute treatment of migraine without the vasoconstrictor activity associated with some migraine therapies. If approved, lasmiditan could represent the first significant innovation in the acute treatment of migraine in more than 20 years.”
To test the effectiveness of the drug, Bernice Kuca, of the clinical and regulatory operations department at CoLucid Pharmaceuticals, and colleagues enrolled 2,231 participants with at least moderate disability (Migraine Disability Assessment score [MIDAS] >11), 1,545 of whom were included in the modified intent-to-treat population. Patients were randomly assigned into one of three groups: 100 mg of lasmiditan (n = 503), 200 mg of lasmiditan (n = 518) or placebo (n = 524) within 4 hours of migraine onset. A second dose was taken 2 to 24 hours later if needed.
At baseline, mean MIDAS was 31.3.
Two hours after the first dose, 32.2% of 200-mg lasmiditan recipients and 28.2% of 100-mg recipients were free from headache pain compared with 15.3% of those who received placebo (P for both < .001). Nausea, photophobia and phonophobia had stopped in 40.7% of the 200-mg lasmiditan recipients, 40.9% of the 100-mg recipients and 29.5% of placebo recipients (P for both < .001).
In addition, Kuca and colleagues found that 29% of participants receiving 200 mg, 36% of those receiving 100 mg and 58% of those receiving placebo needed a second dose.
However, when compared with placebo, more participants taking lasmiditan had a treatment-emergent adverse event; the most common events with lasmiditan after the first dose were somnolence, paresthesia, nausea, lethargy, fatigue and dizziness.
“Though there are different acute therapies approved to manage the symptoms of migraine, there are still a large number of people who are poorly served by currently available therapies, including those with CVD or risk factors. We hope these results are a significant step forward in the development of new acute migraine treatments for the millions of patients in need,” Kinchen said, adding that lost productivity and health care costs for the 36 million Americans living with migraines may be as much as $36 billion per year.
Eli Lilly plans to submit a new drug application for lasmiditan to the FDA in the second half of 2018, according to Kinchen. – by Janel Miller
Kuca B, et al. Lasmiditan (200 mg and 100 mg) compared to placebo for acute treatment of migraine. Presented at: PAINWeek; Sept. 5-9, 2017; Las Vegas.
Healio Family Medicine was unable to obtain researchers’ relevant financial disclosures at the time of publication.