NEW YORK & BUDAPEST, Hungary--Forest Laboratories, Inc. (NYSE:FRX) and Gedeon Richter Plc. today announced positive topline results from a Phase IIb trial evaluating the efficacy and safety of the investigational antipsychotic cariprazine as adjunctive treatment in adult patients with Major Depressive Disorder (MDD) who have demonstrated an inadequate response to antidepressant therapy (ADT).
The trial consisted of three treatment groups, cariprazine 1.0 – 2.0 mg/day + ADT and cariprazine 2.0 – 4.5 mg/day + ADT, and placebo + ADT. The group who received cariprazine 2.0 – 4.5 mg/day + ADT demonstrated statistically significant improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) total score versus placebo at 8 weeks, the primary endpoint.
"Forest is committed to addressing the therapeutic needs of people living with MDD as part of our growing mental health portfolio, and we are excited at the prospect to one day offer a new treatment option for appropriate patients seeking an alternative treatment to manage the condition," said Marco Taglietti, M.D., Chief Medical Officer and EVP, Drug Development and Research at Forest Laboratories, Inc.
"We are encouraged by the positive top-line results shown in this Phase IIb study," said Dr. Zsolt Szombathelyi, Research Director of Gedeon Richter Plc. "We are committed to continuing the development of cariprazine in CNS disorders."
About this Phase IIb Study
This international, multicenter, randomized, double-blind, placebo-controlled, parallel-group, flexible-dose, 8-week Phase IIb study evaluated the efficacy, safety, and tolerability of cariprazine as adjunctive treatment in adult patients with MDD who demonstrated an inadequate response to ADT. Eligible patients were those who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for MDD, had a minimum score of 22 on the MADRS scale, and had an ongoing inadequate response to ADT.
Following a 7-14 day screening and washout period, a total of 819 patients between 18 and 65 years of age were randomized to one of three treatment groups (either cariprazine 1.0 – 2.0 mg/day + ADT, cariprazine 2.0 – 4.5 mg/day + ADT, or placebo + ADT) followed by a 1-week safety follow-up period. The primary endpoint was defined as change from baseline to end of week 8 in the MADRS total score. Statistically significant improvement in the MADRS total score was observed in the cariprazine 2.0 – 4.5 mg/day + ADT group relative to the placebo + ADT treatment group (cariprazine 2.0 – 4.5 mg/day + ADT: -2.2, p=0.0114 and cariprazine 1.0 – 2.0 mg/day + ADT: -0.9, p=0.2404) by MMRM analysis.
Across both cariprazine dose groups the most common adverse events (incidence ≥10% and greater than placebo) were akathisia, nausea, insomnia, somnolence, and fatigue.
Cariprazine, an investigational drug, is an orally active, potent dopamine D3-preferring D3/D2 receptor partial agonist atypical antipsychotic. It has a low affinity at other receptor sites such as 5-HT2C, muscarinic, and adrenergic receptor sites. Cariprazine is protected by a composition-of-matter patent that expires in 2027 without patent term extension.
Cariprazine is being developed for the treatment of schizophrenia and bipolar mania in adults. On November 21, 2013 the companies announced that the U.S. Food and Drug Administration issued a complete response letter regarding the new drug application for schizophrenia and bipolar mania. In addition, there are ongoing investigational clinical trials for the treatment of bipolar depression and as adjunctive treatment of major depressive disorder in adults.
About Major Depressive Disorder
MDD is a serious medical condition often requiring treatment, affecting almost 16 million adults in the United States yearly or approximately 7.3% of the adult U.S. population. MDD, also known as depression, is a common debilitating disorder in which feelings of sadness and other symptoms occur nearly every day for at least two weeks and interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Among all medical illnesses, MDD is a leading cause of disability in the U.S. The World Health Organization predicts depression will become the second leading cause of disability by the year 2020.
About Gedeon Richter Plc.
Gedeon Richter Plc. (www.richter.hu) headquartered in Budapest/Hungary, is a major pharmaceutical company in Central Eastern Europe, with an expanding direct presence in Western Europe. Richter's consolidated sales were approximately EUR 1.2 billion (USD 1.6 billion) while its market capitalization amounted to EUR 2.8 billion (USD 3.8 billion) in 2013. The product portfolio of the Company covers almost all important therapeutic areas, including gynecology, central nervous system, and cardiovascular. Having the largest R&D unit in Central Eastern Europe, the Company's original research activity focuses on CNS disorders. With its widely acknowledged steroid chemistry expertise, Richter is a significant player in the female healthcare field worldwide. Richter is also active in the scope of biosimilar product development.
About Forest Laboratories
Forest Laboratories (NYSE: FRX) is a leading, fully integrated, specialty pharmaceutical company largely focused on the United States market. The Company markets a portfolio of branded drug products and develops new medicines to treat patients suffering from diseases principally in the following therapeutic areas: central nervous system, cardiovascular, gastrointestinal, respiratory, anti-infective, and cystic fibrosis. Our strategy of acquiring product rights for development and commercialization through licensing, collaborative partnerships, and targeted mergers and acquisitions allows us to take advantage of attractive late-stage development and commercial opportunities, thereby managing the risks inherent in drug development. 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 assumes no obligation to update forward-looking statements contained in this release to reflect new information or future events or developments.