Lilly REYVOW treatment of migraine phase 2 clinical results were positive

, Lilly announced the positive results of the recently completed Phase 2 clinical study CENTURION at the PAINWeek 2020 Live Network Conference. Studies have shown that adult patients with migraine attacks received 100 mg or 200 mg of REYVOW™ C-V (lasmiditan, ramiditan) 3.8 times and 4.6 times more pain relief in two hours of treatment than those who took a placebo.The CENTURION study evaluated the effectiveness and safety of REYVOW in acute treatment of migraines in adults, including consistency in the response to the drug treatment in four migraine episodes, regardless of whether the patient had precursor symptoms. In the study, 1,471 migraine patients were randomly divided into two groups and received at least one REYVOW 200mg (n=486), 100mg (n=485) or placebo-controlled treatment (not all seizures were treated with a placebo, n=500) within 4 hours of each migraine attack. Common primary outcome endpoints include pain relief within 2 hours of the first episode, pain relief within 2 hours of two of the two episodes, and secondary endpoints include pain relief at 60 minutes, continuous pain relief at 24 and 48 hours, pain relief within 1 hour and 2 hours, for a total of 18 patient-centered study endpoints. The results of the patient's efficacy 30 minutes, 60 minutes, and 2, 4, 6, 24 and 48 hours after the drug is given will be entered into an electronic journal.

that REYVOW outperforms placebos in pain relief are as follows:Pain relief effects of 2 hours and 60 minutesThe results showed that patients treated with REYVOW 200mg achieved pain relief (common primary endpoint) 4.6 times (29.3% to 8.4%; OR:4.6; p<001) in 2 hours, with a therapeutic gain of about 21%.
study participants who took REYVOW 100 mg were 3.8 times more likely to get pain relief in 2 hours (25.8 percent to 8.4 percent ;p<0.001) than in the placebo group, with a therapeutic gain of about 17 percent.
at 60 minutes, patients treated with REYVOW 200mg were seven times more likely to receive pain relief (12.7% to 2.0% ;p<0.001) than in the placebo group.
was not a study endpoint, 6.0 percent of patients had pain relief one hour after receiving REYVOW 100mg, up from 2.0 percent in the placebo group.

pain relief results of 24 and 48 hoursCompared to the placebo group, patients treated with REYVOW 200mg were 4.7 times more likely to achieve continuous pain relief in 24 hours (17.3 percent to 4.3 percent) and patients treated with REYVOW 100mg were 3.5 times more likely to receive REYVOW 100mg (13.6 percent to 4.3 percent ;p<00.001).
patients treated with REYVOW 200mg were 4.1 times more likely to receive continuous pain relief at 48 hours (15.4% to 4.3% ;p<0.001) in the placebo group.
although not a study endpoint, 9.3 percent of patients continued to have pain relief after 48 hours of REYVOW 100mg treatment, up from 4.3 percent in the placebo group.
lilly points out that REYVOW has an advantage over placebos in patients who relieve pain, get rid of disability, and have a history of treatment with Triptan. The results were as follows:
about 60% of patients treated with REYVOW reduced their migraine pain after 2 hours: 65.2% and 65.4% in the 200mg and 100mg dose groups, respectively, and 41.3% in the placebo group (p<0.001 per comparison).
at 60 minutes, almost 50 per cent of patients treated with REYVOW achieved pain relief: 47.2 per cent and 48.7 per cent in the 200mg and 100mg dosage groups, respectively, compared with 29.3 per cent in the placebo group (p<0.001).
When asked whether migraines affected daily activity 2 hours after treatment, nearly 20 percent of patients treated with REYVOW reported no longer affecting (19.8 percent and 18.6 percent in the 200mg and 100mh dosage groups), about twice as many as in the placebo group (9.5 percent ;p<0.001).
For those with migraine episodes that had been treated ineffectively, inlerable or contraindicated (n-579), the number of people who had pain relief within 2 hours of REYVOW treatment was nearly three times higher than in the placebo group (8.8%) (25.6% and 24.0% ;p<001, respectively, in the 200mg and 100mg dosage groups).
safety results observed in the CENTURION study were consistent with previous REYVOW clinical trials. The rates of severe treatment of sudden adverse events (TEAEs) were similar among the treatment groups: REYVOW 200 mg (n=2 (0.4%)), 100 mg (n=1 (0.2%)) and placebo (n=2 (0.4%). REYVOW is a new type of oral drug that binds closely to a 5-HT1F subject located in the nerve center and outer center, which may play a role in migraines. In October 2019, REYVOW became the first and only FDA-approved "ditan" class of drugs, and the first new class of acute migraine therapy drugs approved by the FDA in more than 20 years for acute treatment (50mg and 100mg) of migraines in adults with or without precursores, but not for migraine prevention. The 5-HT1F-subjected astrogen is a brain osmosis agent that may play a therapeutic role by activating the 5-HT1F-subject, but the exact mechanism is unclear. (Sina Pharmaceutical News)

: REYVOW™ C-V Marched Pain from Migraine Attacks At 60 Minutes and Up to 48 Hours in New Phase 3 study