Phase 3 Trial of Cariprazine (Vraylar) Shows Promise in Bipolar Depression Interview with:

Dr. C. David Nicholson, PhD Chief R&D Officer  Allergan

Dr. C. David Nicholson

Dr. C. David Nicholson, PhD
Chief R&D Officer
Allergan What is the background for this data milestone? 

Response: Bipolar I depression refers to the depressive episodes of bipolar I disorder, the overarching brain and behavioral disorder. People with bipolar I disorder can have manic and depressive episodes, as well as mixed episodes that feature both manic and depressive symptoms at the same time. Bipolar I depression typically lasts at least two weeks, and can be difficult to differentiate from major depression during diagnosis.

Once diagnosed, treating bipolar depression can be difficult given the few therapies available to manage these symptoms of bipolar I disorder. Additionally, patients with bipolar disorder may experience shifts from depression to mania or mania to depression as well as mixed states. More treatment options are needed so that physicians can find a therapy that will treat bipolar depression effectively, while also addressing the myriad of other symptoms that patients can experience.

Cariprazine is already approved for the treatment of mania and mixed episodes. With this new data, we have the potential to also treat bipolar depression, effectively addressing the full spectrum of symptoms associated with bipolar I disorder with just one medication. What are the main findings of the study?

Response: This Phase 3 study (RGH-MD-53), is the third positive pivotal trial of cariprazine in bipolar I depression. A total of 493 patients were randomized in this study aiming to evaluate the efficacy, safety, and tolerability of cariprazine 1.5 mg/day and 3 mg/day compared to placebo in patients with bipolar I depression.

The primary and key secondary efficacy endpoints were met for the cariprazine 1.5 mg dose group. Cariprazine 1.5 mg showed a significantly greater improvement than placebo for the change from baseline to week 6 on both the primary efficacy parameter, the Montgomery-Asberg Depression Rating Scale (MADRS) total score, as well as the key secondary parameter, the Clinical Global Impression-Severity scale (CGI-S). Cariprazine 3 mg showed a numerical improvement over placebo for both the primary and secondary parameters, but did not reach statistical significance. What should readers take away from this announcement? 

Response: The goal of our clinical development program for cariprazine is to improve the severity of all mood changes associated with bipolar disorder, from mania to depression. These symptoms cause significant personal distress, and can often have serious implications for a patient’s health. Having results from a third study demonstrating efficacy in bipolar depression establishes cariprazine as a promising new treatment that can treat both poles of bipolar disorder. Is there anything else you would like to add about the data and what it means for people living with bipolar I depression?

Response: Bipolar I disorder varies greatly from person to person, and so does the right medication. More treatment options are needed so that physicians can find a treatment that works best for each individual. With this trial, Allergan will have sufficient data to submit to the U.S. Food and Drug Administration so that cariprazine may be evaluated as a potential new treatment option for adults struggling to manage their bipolar I depression. 

Press release:

Allergan plc. and Gedeon Richter plc. announced positive topline results for RGH-MD-53, a Phase 3 study of cariprazine for the treatment of adults with major depressive episodes associated with bipolar I disorder (bipolar I depression).

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