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Reyvow showed significant therapeutic gains of 17-21% for pain freedom at 2 hours and met all 18 gated endpoints. Eli Lilly
Adults who took Reyvow (lasmiditan) C-V from Eli Lilly, 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 III study CENTURION . Additionally, Eli Lilly and Company's 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.
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. 1.Pain Freedom Outcomes at 2 Hours and at 60 Minutes : Study results show that people receiving Reyvow 2 00 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<0.001), with a therapeutic gain of approximately 21%. study participants taking reyvow 100 mg had 3.8 times greater odds of achieving pain freedom at 2 hours than those on placebo (25.8% vs. 8.4%; p><0.001), with a therapeutic gain of approximately 17%. these therapeutic gains capture the differences between reyvow and placebo groups in the percentages of patients who were pain-free at 2 hours. at 60 minutes, people who took reyvow 200 mg had 7 times greater odds of achieving pain freedom than those on placebo (12.7% vs. 2.0%; p><0.001). although not a gated endpoint, 6.0% of people receiving reyvow 100 mg were pain-free at 1 hour vs. 2.0% on placebo. 2. sustained pain freedom outcomes at 24 and 48 hours : study participants receiving reyvow 0 mg had 4.7 times greater odds to reach sustained pain freedom at 24 hours than those on placebo (17.3% vs. 4.3%), and those receiving reyvow 100 mg had 3.5 times greater odds compared to placebo (13.6% vs. 4.3%; p><0.001 each). people receiving reyvow 200 mg had 4.1 times greater odds of achieving sustained pain freedom at 48 hours than those receiving placebo (15.4% vs. 4.3%; p><0.001). although not a gated endpoint, 9.3% of people taking reyvow 100 mg had sustained pain freedom at 48 hours, compared to 4.3% for placebo. reyvow superiority compared to placebo in pain relief, no disability and group with prior triptan history. pain relief is defined as headache pain that reduced to mild or resolved completely. 1.pain relief outcomes at 2 hours and at 60 minutes : nearly two-thirds of people on reyvow reported pain relief at 2 hours, 65.2% and 65.4% for reyvow 200 mg and 100 mg, respectively, compared to 41.3% taking placebo (p><0.001 for each comparison). at 60 minutes, almost half of participants on reyvow achieved pain relief, 47.2% for those taking reyvow 200 mg and 48.7% for those on reyvow 100 mg, compared to 29.3% for those on placebo (p><0.001 each). 2. disability outcomes at 2 hours and group with prior triptan history outcomes at 2 hours : when patients were asked whether their migraine interfered with daily activities at 2 hours after treatment, nearly one in five of those taking reyvow reported that no longer was the case (19.8% for 200 mg dose and 18.6% for 100 mg dose), approximately twice the proportion of people on placebo (9.5%; p><0.001 for each reyvow comparison to placebo). for study participants who had previously tried triptans that proved ineffective, intolerable or became contraindicated in treating their migraine attacks (n="579)," close to three times as many people on reyvow were pain-free at 2 hours (24.0% for 100 mg dose and 25.6% for 200 mg dose), compared to those taking placebo (8.8%; p><0.001 for each reyvow comparison to placebo). safety finding : observed safety findings in the centurion study were generally consistent with those seen in previous reyvow clinical trials. the incidence of serious treatment-emergent adverse events (teaes) during the study was similar across treatment arms: reyvow 200 mg [n="2" (0.4%)], reyvow 100 mg [n="1" (0.2%)] and placebo [n="2" (0.4%)]. the most frequent teaes seen after treatment for the first attack for reyvow (?2% in either dose group in the first attack) included 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.>0.001>0.001>0.001>0.001>0.001).>0.001>0.001).>0.001),>0.001),>
Condition: Migraine/Headache
Type: drug