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INDIANAPOLIS, Sept. 11, 2020 /PRNewswire/ -- Adults who took REYVOW™ (lasmiditan) C-V for their migraine attacks at doses of 100 mg or 200 mg had 3.8 and 4.6 times greater odds, respectively, of achieving pain freedom at 2 hours compared to those taking placebo (co-primary endpoint), according to results from the recently completed Phase 3 study CENTURION. Additionally, Eli Lilly and Company's (NYSE: LLY) REYVOW demonstrated superiority over placebo in all gated endpoints, including proportions of study participants who after treating their first migraine attack reported pain freedom at 1 hour (200 mg dose), pain relief at 1 hour and 2 hours (both doses), sustained pain freedom at 24 hours (both doses) and 48 hours (200 mg dose), and no disability at 2 hours (both doses). These results are being presented virtually at the PAINWeek® 2020 Live Virtual Conference, Sept. 11-13.
"For the 30 million adults in the U.S. living with migraine attacks, this debilitating neurologic disease often disrupts daily activities and sidelines them in moments that matter," said Mark Mintun, M.D., vice president of pain and neurodegeneration, Eli Lilly and Company. "We are delighted that REYVOW met all 18 patient-centric endpoints. These new clinical insights into REYVOW's efficacy should enable healthcare providers to have more meaningful conversations with people with migraine who seek freedom from their painful attacks."
The CENTURION study assessed REYVOW's efficacy and safety, including consistency of response, in the acute treatment of migraine for adults, with or without aura, across four attacks. In the trial, 1,471 people with migraine were randomized and received at least one dose of either REYVOW 200 mg (n=486), REYVOW 100 mg (n=485) or control treatment (placebo for some but not all attacks, n=500) per attack. Study participants treated a migraine attack when their pain was at least of moderate severity and within 4 hours after pain onset. Co-primary efficacy endpoints included pain freedom at 2 hours for the first attack and pain freedom at 2 hours for 2 of 3 attacks. Secondary endpoints included pain freedom at 60 minutes, sustained pain freedom at 24 and 48 hours, and pain relief at 1 hour and 2 hours, among others. Patients entered results into an electronic diary at 30 minutes, 60 minutes, as well as 2, 4, 6, 24 and 48 hours after dosing. All of the study's treatment comparisons were prespecified and 18 endpoints were gated, meaning they were set before the study ended and each comparison was reviewed separately in a specified order to verify the accuracy of the study results.
REYVOW SUPERIORITY COMPARED TO PLACEBO IN PAIN FREEDOM
Pain freedom is defined as a reduction of pain at baseline to no pain.
Pain Freedom Outcomes at 2 Hours and at 60 Minutes
Study results show that people receiving REYVOW 200 mg had 4.6 times greater odds of achieving pain freedom at 2 hours (co-primary endpoint) than those on placebo (29.3% vs. 8.4%; odds ratio: 4.6; p
