Core Insights - Reviva Pharmaceuticals announced positive preliminary topline data for brilaroxazine, demonstrating favorable long-term safety and robust broad-spectrum efficacy sustained over one year in patients with schizophrenia [1][2][3] Group 1: Efficacy and Safety Findings - Brilaroxazine showed dose-dependent efficacy with significant decreases in PANSS total scores: -15.2, -18.6, and -20.8 points for doses of 15 mg, 30 mg, and 50 mg respectively [3][4] - The pooled data indicated a clinically meaningful and sustained long-term efficacy with an 18.6-point decrease in PANSS total scores, a 5.2-point decrease in PANSS positive symptoms, and a 4.5-point decrease in PANSS negative symptoms, all with p ≤ 0.0001 [3][4] - The treatment was generally well tolerated, with only 15.2% of participants reporting at least one treatment-related adverse event, mostly mild or moderate in severity [4][5] Group 2: Study Design and Participant Details - The open-label extension (OLE) of the RECOVER study included 435 patients across three dose groups: 139 in 15 mg, 155 in 30 mg, and 141 in 50 mg [2][3] - The study comprised 156 rollover participants from the double-blind portion and 279 de novo participants, with preliminary efficacy results presented for 113 patients who completed one year of treatment [2][3] Group 3: Future Outlook - Full data from the OLE portion of the RECOVER study, including long-term safety, tolerability, and efficacy data, is expected to be reported in Q1 2025 [1][2] - Reviva aims to submit a New Drug Application (NDA) to the FDA based on the long-term safety data from at least 100 patients who completed one year of treatment [5][9]
Reviva Announces Positive Preliminary Topline Data for the Long-Term Open Label Extension Portion of the Phase 3 RECOVER Study Evaluating Brilaroxazine in Schizophrenia