Cariprazine was approved by the FDA in September 2015 and is marketed as VRAYLAR™ in the US for the treatment of manic or mixed episodes of Bipolar I Disorder and Schizophrenia in adults.
MD-72 Adjunctive MDD Trial
The MD-72 trial was a prospective, randomized, double-blind, placebo-controlled, parallel-group study evaluating flexible doses of cariprazine (1.5- 4.5 mg) as an adjunctive treatment to antidepressant therapy in adults with major depressive disorder (MDD) who failed to adequately respond to antidepressant monotherapy. The study was conducted at multiple centers, all within the United States.
Topline results from the MD-72 trial indicate that flexible doses of cariprazine did not separate significantly from placebo as an add-on treatment in this trial. In a previously conducted trial (MD-75), flexible doses of cariprazine (2-4 mg) were significantly more effective than placebo as an adjunctive treatment to antidepressant therapy in adults with major depressive disorder (MDD) who failed to adequately respond to antidepressant monotherapy.
It is not uncommon that clinical trials in MDD fail to show a separation from placebo even with effective drugs. Both companies remain committed to developing cariprazine as a potential treatment option for patients suffering from this serious illness and will continue to work on a subsequent Phase 3 trial.
"We are disappointed with the results of this trial. However, we believe that our plan to move forward with another Phase 3 study in Adjunctive MDD coupled with our previous positive clinical trial would provide the two studies needed for submission. This is an important next step to further develop the cariprazine program," Chief R&D Officer at Allergan.
Patient Enrollment underway for Bipolar Depression trials
Allergan and Richter have started the patient enrollment in their Phase 3 clinical trial program investigating the use of cariprazine as a treatment for bipolar depression. Two parallel studies will be conducted at approximately 85 sites across the U.S. and Europe.
The companies have previously announced positive Phase 2b data for cariprazine for the treatment of bipolar depression. This data was published in in the Journal of American Psychiatry in November 2015.
Additional development programs in Prevention of Schizophrenia Relapse and Predominant Negative Symptoms of Schizophrenia
In January 2015 Gedeon Richter and Allergan announced positive phase 3 trial results for cariprazine in the prevention of relapse of schizophrenia symptoms in adult patients. The companies are planning to submit an efficacy supplement that will provide for the maintenance of efficacy in schizophrenia patients.
In January 2015, Gedeon Richter announced a positive Phase 3 study that evaluated cariprazine for the treatment of predominant negative symptoms (PNS) of schizophrenia. Both companies are in active discussions with FDA regarding the submission of an efficacy supplement to provide for the treatment of PNS. Based on our current regulatory interactions we intend to file in the first half of 2017.
PNS is a serious unmet need for which there are no approved treatment options available.
About VRAYLAR (cariprazine)
VRAYLAR is an oral, once daily atypical antipsychotic approved for the acute treatment of adult patients with manic or mixed episodes associated with bipolar I disorder, with a recommended dose range of 3 to 6 mg/day and for the treatment of schizophrenia in adults, with a recommended dose range of 1.5 to 6 mg/day.
Please also see full Prescribing Information, including Boxed Warning, at www.vraylar.com.
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, the Company's R&D model, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 70+ mid-to-late stage pipeline programs in development.
Our Company's success is powered by our more than 16,000 global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
For more information, visit Allergan's website at www.Allergan.com.
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2016 (such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
About Gedeon Richter
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. Having reached a market capitalisation of EUR 3.3 billion (US$ 3.6 billion) by the end of 2015, Richter's consolidated sales were approximately EUR 1.2 billion (US$ 1.3 billion) during the same year. The product portfolio of Richter covers many important therapeutic areas, including gynaecology, central nervous system, and cardiovascular areas. Having the largest R&D unit in Central Eastern Europe, Richter'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 biosimilar product development.
For more information:
Zsuzsa Beke: +36 1 431 4888
Fran DeSena (973) 517-3132
Mark Marmur (862) 261-7558