Forest Laboratories, Inc. (NYSE: FRX) and Gedeon Richter Plc today announced preliminary top-line results from a Phase III clinical trial of cariprazine (RGH-188), an investigational antipsychotic agent, in patients with acute mania associated with bipolar I disorder. For the primary endpoint, the Young Mania Rating Scale (YMRS), the data showed that cariprazine-treated patients with acute manic episodes experienced significant symptom improvement compared to placebo-treated patients seen as early as day four of treatment and at each subsequent time point studied. Further analyses of the data will be completed in the coming weeks. Cariprazine is also being investigated in clinical studies for patients with schizophrenia, bipolar depression, and as an adjunct treatment in MDD.

“These exciting positive Phase III results in patients with bipolar mania demonstrate the potential of cariprazine as a novel antipsychotic agent,” said Marco Taglietti, MD., Senior Vice President of Research and Development and President, Forest Research Institute. “We will continue to investigate the therapeutic benefits of this novel dual acting D3/D2 compound across other CNS disorders as well.”

"We are encouraged by the positive top-line results shown in this Phase III study. These data together with those of the Phase II program prove that cariprazine provides a clinically meaningful improvement with good tolerability in patients with acute mania associated with bipolar I disorder. It also confirms, the D3/D2 partial agonist research concept elaborated by Richter’s researchers was a valuable and novel approach,” commented Zsolt Szombathelyi, M.D., Research Director of Gedeon Richter Plc.

About the Study

This Phase III, multicenter, double-blind, placebo- controlled, parallel-group study evaluated the efficacy, safety, and tolerability of cariprazine monotherapy in patients with acute mania associated with bipolar I disorder. During the five-week study, 312 men and women, 18-65 years of age meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder were randomized and received at least one dose of either cariprazine, 3-12mg/day (N=158), or placebo (N=154). Following wash-out screening period of four to seven days, patients were given 1-4 capsules (cariprazine or placebo) daily. The treatment period lasted three weeks and was followed by a two week period of safety assessments. Patients were hospitalized throughout screening and for at least the first 14 days following initiation of treatment.

The primary, protocol-specified, endpoint was change from baseline to Week 3 on the YMRS, using the mixed effects model of repeated measures (MMRM) analysis. The YMRS is a comprehensive, clinician-rated instrument used to assess the severity of mania in bipolar patients, and includes such parameters as elevated mood, increased motor activity energy, sleep, and irritability. Statistically significant improvement was noted in patients receiving cariprazine (3-12mg/day) relative to patients receiving placebo on the YMRS scale (-19.6 cariprazine vs. -15.3 placebo, p

Forest Road Acquisition (NYSE:FRX)
Historical Stock Chart
From Jun 2024 to Jul 2024 Click Here for more Forest Road Acquisition Charts.
Forest Road Acquisition (NYSE:FRX)
Historical Stock Chart
From Jul 2023 to Jul 2024 Click Here for more Forest Road Acquisition Charts.