Clinical Trials

Date: 2016-08-05

Type of information: Results

phase: 3

Announcement: results

Company: Gedeon Richter (Hungary) Allergan (Ireland)

Product: cariprazine

Action mechanism:

• dopamine D3 receptor partial agonist. Cariprazine has been discovered by researchers at Gedeon Richter. This orally active, potent dopamine D3-preferring D3/D2 receptor partial agonist is an atypical antipsychotic for the treatment of patients with schizophrenia and for patients with manic or mixed episodes associated with bipolar I disorder. The safety and efficacy of cariprazine was studied in a clinical trial program of more than 2700 patients. In addition, cariprazine is being investigated for the treatment of bipolar depression and adjunctive MDD in adults. Cariprazine is licensed to Actavis, now Allergan, in the U.S. and Canada.
• 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.

Disease: major depressive disorder

Therapeutic area: CNS diseases - Mental diseases

Country: USA

Trial details:

• The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD. (NCT01715805 )

Latest news:

• • On August 5, 2016, Allergan and Gedeon Richter provided a clinical and regulatory update on cariprazine. For more than a decade both companies have conducted over 20 clinical trials enrolling thousands of patients worldwide to evaluate the efficacy and safety of cariprazine for patients suffering from a broad range of mental health illnesses.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," said David Nicholson , Chief R&D Officer at Allergan . Allergan and Gedeon 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. The companies  intend to file in the first half of 2017.

Is general: Yes