A late-stage study assessing Allergan/Gedeon Richter’s cariprazine for the treatment of adults with major depressive episodes associated with bipolar I disorder has hit its primary target.
Top-line results from the Phase III trial show that the primary efficacy objective was met for both cariprazine 1.5mg and 3mg formulations, with showing a significantly greater improvement than placebo for the change from baseline to week 6 on the Montgomery-Asberg Depression Rating Scale (MADRS) total score, the firms noted.
Also, the drug was well-tolerated in the study, with sedation, somnolence, dizziness, akathisia and nausea the most commonly reported adverse events. Five percent of cariprazine treated patients discontinued due to adverse events versus 2.5 percent of those in the placebo arm.
On the back of the data, a supplemental New Drug Application (sNDA) will be filed with US regulators in the second half of next year, the Dublin, Ireland-headquartered group said.
Cariprazine is already on the market under the trade name Vraylar as an oral, once-daily, atypical antipsychotic for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder, and for the treatment of schizophrenia in adults.
"There are a limited number of products approved to treat bipolar depression and even fewer products that have been studied and approved to treat the full spectrum of bipolar disorder, from mania through depression,” commented Gary Sachs, MD, Associate Clinical Professor of Psychiatry at Harvard Medical School.
“Having another product proven to treat the full range of bipolar disorder would be a welcome addition to the treatment options currently available to the psychiatry community and patients.”