In a phase 3 study (NCT02439320) of lasmiditan (Reyvow; Eli Lilly and Company, Indianapolis, IN), which is an approved treatment for migraine with or without aura, participants treated with 200 mg of lasmiditan had a 4.6 times higher odds ratio (OR) for achieving freedom from pain at 2 hours compared with those treated with placebo (29.3% vs 8.4%; P<.001). Participants treated with 100 mg of lasmiditan had a 3.8 times higher OR for achieving pain freedom at 2 hours compared with placebo treatment (25.8% vs. 8.4%; P<.001).
At 60 minutes posttreatment, 12.7% of people who took lasmiditan 200 mg had freedom from pain compared with 2.7% of those who took placebo (P<.001). Participants who took 100 or 200 mg lasmiditan, respectively, were 3.5 and 4.1 times more likely to have sustained freedom from pain at 24 hours compared with those who took placebo (13.6% and 17.3%, respectively, vs 4.3%; P<.001). At 48 hours posttreatment, 9.3% and 15.4% of participants who took lasmiditan 100 or 200 mg, respectively, had sustained freedom from pain compared with 4.3% of those who received placebo.
"Migraine attacks affect patients in different ways, so it's important patients have options to help achieve their individual treatment goals," said study investigator and co-author Uwe Reuter, M.D., Ph.D., professor of neurology, Charite University Hospital of Berlin, Berlin, Germany. "I'm encouraged by this study, in which we saw REYVOW helped patients be pain-free in as early as 60 minutes and for up to 48 hours."
Of those treated with 200 or 100 mg of lasmiditan, 65.2% and 65.4%, respectively, had pain relief at 2 hours compared with 41.3% treated with placebo (P<.001 for each comparison). At 60 minutes, 48.7% and 47.2% of those taking lasmiditan 100 or 200 mg, respectively, had pain relief vs 29.3% of those taking placebo (P<.001 for each comparison).
When participants were asked whether migraine interfered with daily activities 2 hours after taking lasmiditan, 18.6% and 19.8% and of those taking 100 mg or 200 mg, respectively reported that it was no longer an issue.
In the study, the efficacy and safety of lasmiditan was assessed, including the participants’ response to treatment consistency across 4 migraine attacks. The study enrolled 1,471 participants with migraine who were randomly assigned to receive at least 1 dose of either lasmiditan 200 mg (n=486), lasmiditan 100 mg (n=485) or control treatment (placebo for some but not all attacks, n=500) per attack.
The most frequent treatment-emergent adverse events included dizziness, paresthesia, fatigue, nausea, vertigo, somnolence, hypoesthesia, muscle weakness, asthenia, and feeling abnormal. Lasmiditan carries a restriction against driving within 8 hours of taking a dose and is a Schedule V controlled substance. Lasmiditan may cause central nervous system (CNS) depression, including dizziness and sedation.
Nidhiben Anadani, MD
Peter McAllister, MD
Bettina Balint, MD