Positive data from RGH-MD-53 study of cariprazine for the treatment of bipolar I depression._Allergan + Gedeon Richter.

Allergan plc and Gedeon Richter Plc ., announced positive topline results for RGH-MD-53, a Phase III study of cariprazine for the treatment of adults with major depressive episodes associated with bipolar I disorder (bipolar I depression). The companies announced in December 2017 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 efficacy of cariprazine in the treatment of bipolar I depression has been demonstrated in three positive pivotal trials, including RGH-MD-53, RGH-MD-54 and RGH-MD-56. Allergan plans to include data from all three pivotal trials in the Company's Supplemental New Drug Application (sNDA) to the FDA 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.

For RGH-MD-53, 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 (p=0.0417, LSMD -2.5), as well as the key secondary parameter, Clinical Global Impression Scale-Severity (CGI-S) (p=0.0417, LSMD -0.3). Cariprazine 3 mg showed a numerical improvement over placebo for both the primary (p=0.1051, LSMD -1.8) and secondary parameters (p=0.1370, LSMD -0.2), but did not reach statistical significance.