Pharma Focus America

Reviva Completes Last Patient Assessment in Crucial Phase 3 RECOVER Trial for Brilaroxazine in Schizophrenia

Monday, September 25, 2023

Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) has made a significant announcement regarding the successful conclusion of patient evaluations in its global pivotal Phase 3 RECOVER trial, which aims to assess the effectiveness of brilaroxazine as a treatment for schizophrenia. Brilaroxazine, characterized as a serotonin-dopamine stabilizer, is being developed by Reviva to address unmet medical needs within the field of central nervous system (CNS) disorders.

In this study, 410 patients with acute schizophrenia participated in a randomized, double-blind, placebo-controlled trial where they were administered brilaroxazine at fixed doses of 15 mg or 50 mg once daily for a period of 28 days. The primary objective of this trial was to evaluate the reduction in the Positive and Negative Syndrome Scale (PANSS) total score compared to the placebo from the baseline to Day 28. Key secondary endpoints encompassed assessments of the clinical global impression (CGI) rating scale, positive and negative symptoms, social functioning, and cognition.

Furthermore, Reviva is planning to conduct a 1-year open-label extension (OLE) study to thoroughly examine the long-term safety and tolerability of brilaroxazine in individuals with stable schizophrenia, providing valuable insights into its extended usage.

Reviva's CEO, Laxminarayan Bhat, underscored the significance of brilaroxazine in addressing the challenges faced by individuals with schizophrenia, including the side effects and drug interactions often associated with current treatment options. Brilaroxazine is meticulously designed to offer a well-tolerated safety profile conducive to extended use while effectively targeting positive, negative, mood-related, cognitive symptoms, and neuroinflammation associated with schizophrenia.

The company anticipates releasing pivotal top-line data from the RECOVER trial in October 2023.

Brilaroxazine represents a newly developed chemical entity created in-house by Reviva, demonstrating potent affinity and selectivity against serotonin and dopamine receptors implicated in schizophrenia and related symptoms. During Phase 2 trials, it exhibited promising results, meeting primary endpoints, and displaying significant improvements in various secondary measures without any adverse effects such as weight gain, increased blood sugar, or lipid levels. Additionally, there were no clinically significant drug-drug interactions observed when brilaroxazine was administered alongside a CYP3A4 inhibitor.

Reviva is actively exploring the potential development of brilaroxazine for other neuropsychiatric conditions, including bipolar disorder, major depressive disorder (MDD), and attention-deficit/hyperactivity disorder (ADHD). Moreover, brilaroxazine has shown promise in addressing inflammatory diseases such as psoriasis, pulmonary arterial hypertension (PAH), and idiopathic pulmonary fibrosis (IPF), and it has been granted Orphan Drug Designation by the U.S. FDA for PAH and IPF.

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