03.04.2018 14:21:33

Allergan, Richter Report Positive Topline Results From Third Cariprazine Trial

(RTTNews) - Allergan plc (AGN) 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 or bipolar I depression.

In December 2017, the companies announced positive topline results for the second pivotal trial (RGH-MD-54) of cariprazine in the treatment of bipolar I depression. In that trial, both cariprazine 1.5mg and 3mg were statistically greater than placebo.

The companies noted that the efficacy of cariprazine in the treatment of bipolar I depression was demonstrated in three positive pivotal trials, including RGH-MD-53, RGH-MD-54 and RGH-MD-56.

For RGH-MD-53, the primary and key secondary efficacy endpoints were met for the cariprazine 1.5 mg dose group. In this study, 493 patients were randomized to placebo, cariprazine 1.5 mg and cariprazine 3 mg treatment groups to evaluate the efficacy, safety and tolerability of cariprazine in patients with bipolar I depression.

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 or MADRS total score as well as the key secondary parameter, Clinical Global Impression Scale-Severity or CGI-S.

Cariprazine 3 mg showed a numerical improvement over placebo for both the primary and secondary parameters, but did not reach statistical significance.

Allergan said it plans to include data from all three pivotal trials in its Supplemental New Drug Application or sNDA to the U.S. Food and Drug Administration in the second half of 2018.

Cariprazine is currently approved in the U.S. under the brand name "Vraylar" for the treatment of schizophrenia in adults, and acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.

"We are very pleased with the results of our third pivotal study, which reinforce the wealth of data supporting cariprazine as a potential treatment in adults with bipolar depression. Bipolar depression is often difficult to treat and can be extremely debilitating for patients," said David Nicholson, Chief Research & Development Officer at Allergan.

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