Reyvow CENTURION trial results : Eli Lilly and Company (Lilly) said that its migraine drug Reyvow (lasmiditan) has met the co-primary endpoint of a phase 3 clinical trial called CENTURION by delivering pain freedom from migraine attacks at 60 minutes and up to 48 hours.
According to the US pharma giant, adults who were given Reyvow C-V for their migraine attacks at 100mg or 200mg doses had 3.8 and 4.6 times greater odds, respectively, of getting freedom from pain at 2 hours compared to those who were given placebo.
Besides, the Lilly migraine drug showed superiority over placebo in all gated endpoints, including proportions of study participants who upon treatment of their first migraine attack had pain freedom at one hour for the 200mg dose, pain relief at one hour and two hours for both doses, sustained pain freedom at 24 hours for both doses and 48 hours for the 200mg dose, and no disability at two hours for both the doses.
The Reyvow CENTURION trial results are being presented at the PAINWeek 2020 Live Virtual Conference, said Lilly.
Mark Mintun – Lilly vice president of pain and neurodegeneration, commenting on the Reyvow CENTURION trial results, said: “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.
“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 phase 3 trial evaluated the efficacy and safety of Reyvow, including consistency of response, in the acute treatment of migraine for adults, irrespective of having aura, across four attacks. A total of 1,471 people having migraine were randomized and were given at least a dose of either Reyvow 200mg, Reyvow 100mg or control treatment (placebo for some but not all attacks) per attack.
In October 2019, Lilly bagged approval from the US Food and Drug Administration (FDA) for Reyvow for the acute treatment of migraine, irrespective of aura (a sensory phenomenon or visual disturbance), in adults. (Read more about Reyvow FDA approval here)