Monotherapy study supports data from prior two trials in same patient population.
Gedeon Richter and partner Forest Laboratories reported postive data from a Phase III study investigating the antipsychotic drug cariprazine (RGH-188) in patients with acute mania associated with bipolar I disorder. The reported five-week Phase III study compared cariprazine monotherapy with placebo in 497 adult patients who met DSM-IV-TR criteria for bipolar I disorder.
The results demonstrated that compared with treatment using placebo, cariprazine-treated patients experienced significant improvements in symptoms at each designated time point, and as early as five days after the start of therapy. The firms say the latest data support those from two previous pivotal placebo-controlled trials with cariprazine in the same patient population.
Cariprazine is an orally active dopamine D3– preferring D3/D2 receptor partial agonist, which was originally discovered at Gedeon Richter. The drug is undergoing Phase II or III clinical development as a treatment for schizophrenia, bipolar depression, and as an adjunct treatment for major depressive disorder. Hungarian firm Gedeon Richter has partnered with Mitsubishi Tanabe to develop cariprazine for the treatment of schizophrenia in Japan.