The REPRIEVE study was a randomized, double-blind, placebo-controlled study designed to evaluate prevention of relapse in adult patients with schizophrenia receiving either flexible dose Fanapt or placebo. Adults with schizophrenia were titrated up to 12mg/day given as 6mg twice daily with open-label Fanapt and then stabilized for a further 14–24 weeks with a flexible dose Fanapt regimen. Subjects who remained clinically stable for at least 12 weeks entered the “Relapse Prevention” phase and were randomized 1:1 to either continue on the same flexible dose regimen of Fanapt or to withdraw from Fanapt to matched placebo in a double-blinded fashion. Patients were followed for up to 26 weeks and were withdrawn upon showing signs of relapse or impending relapse. The primary outcome was time-to-relapse or impending relapse using the interim analysis population.
Of the 587 patients entering the “Stabilization” phase, 195 (33%) met the criteria for the double-blind Relapse Prevention phase, with 99 subjects randomized to continue with Fanapt and 96 to switch to placebo. The study was stopped early after 68 events were observed and confirmed the hypothesis that Fanapt was more effective than placebo in relapse preventions (P<0.0001). The percentage of Fanapt patients remaining relapse free at the end of the double-blind Relapse Prevention phase was of 79.6% compared to 36.6% for placebo-treated patients. The mean time to relapse was 71 days for placebo and 139 days for Fanapt subjects.
Fanapt is an atypical antipsychotic agent already indicated for the treatment of schizophrenia in adults. Vanda plans to file a supplemental New Drug Application (sNDA) for Fanapt with the Food and Drug Administration (FDA) in the second half of 2015 to include the results from the REPRIEVE study in the Fanapt package insert.
For more information call (202) 734-3400 or visit VandaPharma.com.