Eli Lilly and Company has reported that its oral drug Reyvow (lasmiditan) C-V demonstrated superior pain freedom in the Phase III consistency of effect study, CENTURION, in patients with migraine attacks.
Reyvow is designed to attach to 5-HT1F receptors located centrally and peripherally. This is said to be the first and only ditan approved by the US Food and Drug Administration (FDA).
The trial, conducted on 1,471 subjects, analysed Reyvow’s efficacy and safety in treating migraine in adults, with or without aura, across four attacks.
Co-primary efficacy endpoints were pain freedom at two hours for the first attack and pain freedom at two hours for at least two of three attacks.
Secondary endpoints were pain relief at two hours after the first attack in at least two of three attacks on those who have used triptans.
Data showed that participants who took 100mg or 200mg dose of the drug Reyvow had 3.8 and 7.2 times greater odds of experiencing migraine pain freedom at two hours compared to placebo in at least two out of three attacks.
This resulted in therapeutic gains of 10% to 20%.
Participants on Reyvow also achieved pain freedom and pain relief at two hours, even though they had tried triptans that proved to be ineffective, unbearable or became contraindicated.
Reyvow also showed superiority over placebo in all 18 gated endpoints of the trial and safety profiles were consistent with the previous trials.
Eli Lily and Company pain and neurodegeneration vice-president Mark Mintun said: “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 two hours in at least two out of three attacks with the 200mg dose are meaningful for patients and healthcare providers who seek consistency as a goal with acute medications when treating migraine attacks.”