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Eli Lilly Reports REYVOW 'Demonstrated Superior Pain Freedom At 2 Hours in At Least 2 of 3 Migraine Attacks in New Phase 3 Consistency of Effect Study'

INDIANAPOLIS, Oct. 6, 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 7.2 times greater odds, respectively, of

· 10/06/2020 06:46

INDIANAPOLIS, Oct. 6, 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 7.2 times greater odds, respectively, of achieving superior pain freedom at 2 hours post treatment compared to those taking placebo in at least 2 out of 3 attacks (co-primary endpoint), new findings from the recently completed Phase 3 study CENTURION reveal. This co-primary endpoint result translated to therapeutic gains, or differences between REYVOW and placebo groups, of approximately 10-20%. Moreover, in at least 2 out of 3 attacks, Eli Lilly and Company's (NYSE:LLY) REYVOW demonstrated superiority over placebo in pain relief at 2 hours. In addition, significantly more study participants who treated their migraine attacks with REYVOW achieved pain freedom and pain relief at 2 hours in 2 out of 3 attacks with REYVOW versus those on placebo, even if they had previously tried triptans that were ineffective, intolerable or became contraindicated. As previously reported, REYVOW demonstrated superiority over placebo in all of the study's 18 gated endpoints. Study investigator Dr. Messoud Ashina, M.D., professor of neurology, Danish Headache Center and Dept. of Neurology, University of Copenhagen, Copenhagen, Denmark and Dr. Uwe Reuter, M.D., Ph.D., professor of neurology, Charite University Hospital of Berlin, Berlin, Germany, are presenting these results and answering questions virtually at the 18th Migraine Trust International Symposium (MTIS 2020), during a session on Oct. 7th, 4:45 – 5:45 p.m. CEDT/10:45 – 11:45 a.m. EDT.

"Healthcare professionals, advocacy groups and people with migraine have made it clear that one of the most important things they want from an acute treatment is consistent efficacy during the first and subsequent attacks," said Mark Mintun, M.D., vice president of pain and neurodegeneration, Eli Lilly and Company. "Not being able to rely on their migraine treatment causes frustration and disappointment when their medicine doesn't work consistently. We are excited about the latest findings from the CENTURION trial. We believe that REYVOW's therapeutic gain of up to 20% and up to 7.2 times greater odds of achieving pain freedom at 2 hours in at least 2 out of 3 attacks with the 200 mg dose are meaningful for patients and healthcare providers who seek consistency as a goal with acute medications when treating migraine 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 treated with 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. This international trial included patients from Austria, Belgium, China, Czechia, Denmark, France, Germany, Hungary, India, Italy, Mexico, Netherlands, Russian Federation, Spain, Switzerland, United Kingdom and the United States of America. Co-primary efficacy endpoints were pain freedom at 2 hours for the first attack, and pain freedom at 2 hours for at least 2 of 3 attacks. Secondary endpoints included pain relief at 2 hours after the first attack and in at least 2 of 3 attacks and findings in the subset of study participants who had previously tried triptans that were ineffective, intolerable or became contraindicated in treating their migraine attacks. 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.

CONSISTENCY OF PAIN FREEDOM AND PAIN RELIEF AT 2 HOURS

Pain freedom and pain relief, respectively, are defined as a reduction of pain at baseline to no pain, and headache pain that reduced to mild or resolved completely.

Study results show that people taking REYVOW 200 mg had 7.2 times greater odds of achieving pain freedom at 2 hours in at least 2 of 3 migraine attacks (co-primary endpoint) than those on placebo (24.4% vs. 4.3%; odds ratio: 7.2; p<0.001), with a therapeutic gain of approximately 20%. People who took REYVOW 100 mg had 3.8 times greater odds of achieving pain freedom at 2 hours in at least 2 of 3 attacks than study participants on placebo (14.4% vs. 4.3%; p<0.001), translating to a therapeutic gain for patients taking REYVOW of approximately 10%.

Nearly 2 out of 3 people taking REYVOW achieved pain relief at 2 hours in at least 2 of 3 attacks, including 66.7% and 62.3% of those taking REYVOW 200 mg and 100 mg, respectively, compared to 36.9% of those on placebo (p<0.001 for each REYVOW comparison to placebo).

CONSISTENCY OF PAIN FREEDOM AND PAIN RELIEF AT 2 HOURS IN GROUP WITH PRIOR TRIPTAN HISTORY

The study also assessed pain freedom and pain relief at 2 hours in at least 2 of 3 migraine attacks in subsets of participants who had previously tried triptans that were ineffective, intolerable or became contraindicated. These outcomes were non-gated secondary endpoints.

Significantly greater proportions of people taking REYVOW were pain-free at 2 hours in at least 2 of 3 migraine attacks (20.1% for REYVOW 200 mg and 11.0% for REYVOW 100 mg), compared to placebo (4.3%) (p<0.001 for each REYVOW comparison to placebo). Nearly 2 out of 3 persons taking REYVOW 200 mg (62.7%) and more than half of participants taking 100 mg (55.6%) achieved pain relief at 2 hours in at least 2 of 3 migraine attacks compared to 1 out of 3 patients (33.6%) on placebo (p<0.001 for each REYVOW comparison to placebo).

"In this study, people taking REYVOW, who had previously tried triptans that were ineffective, intolerable or contraindicated, achieved significantly greater pain freedom and pain relief at 2 hours across multiple attacks compared to those taking placebo," said Dr. Ashina. "These latest findings are encouraging news for patients and their healthcare providers when discussing personalized treatment goals such as consistency of response. Migraine attacks can be debilitating so it's imperative patients have acute treatment options that can help them achieve the outcomes that matter to them."

SAFETY FINDINGS

Observed safety findings in the CENTURION study were generally consistent with those seen in previous REYVOW clinical trials. The most frequent treatment-emergent adverse events (TEAEs) seen for REYVOW (≥2% in either dose group) over all four attacks were dizziness, paresthesia (tingling), fatigue, nausea, vertigo (sensation of spinning or movement), somnolence (sleepiness), hypoesthesia (diminished sensation), muscle weakness, asthenia (abnormal physical weakness) and feeling abnormal. The incidence of TEAEs was highest during the first attack.

"Among recently approved novel medications for the acute treatment of migraine, REYVOW is the first and only to be evaluated in a consistency study. Additionally, CENTURION is one of the only studies of an FDA-approved acute treatment for migraine to compare the consistency of efficacy against placebo," said Ilya Yuffa, president of Lilly Bio-Medicines. "We are delighted that REYVOW demonstrated consistent and superior efficacy across multiple migraine attacks compared to placebo. These are meaningful insights for patients and their healthcare providers, and we look forward to sharing the findings with health regulatory authorities in Europe, Japan and China."

ABOUT REYVOW® (lasmiditan) TABLETS

REYVOW is a novel oral medication that strongly binds to 5-HT1F receptors located both centrally and peripherally, which may play a role in migraine, a neurologic disease. REYVOW is approved for the acute treatment of migraine with or without aura in adults and is not indicated for the preventive treatment of migraine. REYVOW, the first and only FDA-approved ditan, is brain-penetrant and presumably exerts its therapeutic effects by activating these receptors; however, the precise mechanism is unknown.