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Allergan and Richter Provide Update on Cariprazine Program in treating depression; Topline results from the MD-72 trial

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Additional Relevant Details MD-72 Adjunctive MDD TrialThe 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.Patient Enrollment underway for Bipolar Depression trialsAllergan 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.
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Occurred on:
Aug 05, 2016
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Related Keywords Cariprazine, Bipolar Depression, Major Depressive Disorder, Md-72 Trial