NEW YORK & BUDAPEST, Hungary--(BUSINESS WIRE)-- Forest Laboratories, Inc. (NYSE: FRX) and Gedeon Richter Plc. today announced preliminary top-line results from an 8-week Phase II clinical trial of the novel, investigational antipsychotic agent cariprazine as adjunctive therapy in major depressive disorder. Cariprazine is currently undergoing Phase III trials for the separate and additional indications of schizophrenia and bipolar mania.
In this exploratory Phase II trial, a total of 231 patients were randomized to enter one of two active (low dose or high dose) treatment arms or placebo. The primary endpoint was the Montgomery Asberg Depression Rating Scale (MADRS) score. Although the overall difference observed between the drug-treated and placebo-treated groups was not statistically significant, over the course of the trial, there was evidence of a treatment effect in the high-dose arm of the study compared to placebo.
In addition, tolerability results for cariprazine support further investigation in this patient population. Approximately 3% of patients discontinued the study early due to adverse events in the high-dose and 1% in the low-dose study arm compared to 3% in the placebo arm.
The companies are considering conducting an additional Phase II dose-response trial examining a wider range of doses.
About the Study
This Phase II trial was a U.S. multicenter, randomized double-blind, placebo-controlled, parallel, flexible-dose group study that evaluated the efficacy, safety and tolerability of once-daily cariprazine in patients with major depressive disorder who failed to respond to at least 2 antidepressant therapies (ADT). Following a washout period of no drug therapy for one week and 8 weeks of prospective ADTs, a total of 231 patients, between ages 18 and 65 years old, were randomized to one of three treatment arms (either 0.1-0.3 mg per day cariprazine + ADT, 1.0-2.0 mg per day cariprazine + ADT, or placebo + ADT). The primary endpoint was defined as change from randomization baseline to end of Week 8 in the MADRS total score.
Cariprazine, discovered by researchers at Gedeon Richter, is an orally active, potent D3/D2 partial agonist that preferentially binds to D3 receptors. Cariprazine also has a relatively low potency at other receptor sites, such as 5-HT2C, histamine H1, and muscarinic and adrenergic receptor sites which have been associated with adverse events. Cariprazine demonstrated a reduction in symptoms in previously reported Phase II clinical trials for schizophrenia and bipolar mania.
About Gedeon Richter Plc.
Gedeon Richter, (http://www.richter.hu) headquartered in Budapest/Hungary, is a major pharmaceutical company in Hungary and one of the largest in Central Eastern Europe, with consolidated sales of approximately 1 billion EUR (1,3 billion USD) and 3 billion EUR (4 billion USD) market capitalization in 2009. Gedeon Richter plays the role of a regional multinational company in Central Eastern Europe and in the CIS and has a growing presence via its strategic partners in the US and through its commercial subsidiaries in key EU countries. The product portfolio of the company covers almost all important therapeutic areas, such as cardiovascular, central nervous system, gynecology, etc. The company has the largest R&D unit in Central Eastern Europe. Original research activity focuses exclusively on CNS disorders with main clinical targets being schizophrenia, anxiety, chronic pain and depression. With its widely acknowledged steroid chemistry expertise the company is a significant player in the female healthcare field worldwide.
About Forest Laboratories
Forest Laboratories’ (NYSE:FRX) longstanding global partnerships and track record developing and marketing pharmaceutical products in the United States has yielded its well-established central nervous system and cardiovascular franchises and innovations in anti-infective medicine. The Company’s pipeline, the most robust in its history, includes product candidates in all stages of development across a wide range of therapeutic areas. The company is headquartered in New York, NY. To learn more, visit www.FRX.com.
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.
Forest Laboratories, Inc.
Frank J. Murdolo, 212-224-6714
Vice President - Investor Relations
KEYWORDS: United States Europe North America New York Hungary
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Pharmaceutical