Gedeon Richter and partner Forest Laboratories reported positive topline data from two Phase III studies evaluating cariprazine (RGH-188) in the treatment of acute exacerbation of schizophrenia. Both studies showed that compared with placebo, cariprazine therapy significantly improved symptoms according to PANSS (positive and negative syndrome scale) scores. The new data follow less than a month after the firms reported positive results from a Phase III study assessing cariprazine in patients with acute mania associated with bipolar I disorder.
One of the Phase III schizophrenia studies was a fixed-dose trial in 617 patients, treated with one of two doses of cariprazine or with aripiprazole or placebo for six weeks. Stasitically significant improvements in PANSS scores were observed in each of the cariprazine dose groups relative to placebo at every time point, starting at week one.
The second, fixed-flexible dose parallel-group study, involved 446 patients who received variable doses of cariprazine or placebo for six weeks. Again, compared with placebo, statistically significant improvements in PANSS scores were recorded at each time point, from one week onward for the 6–9 mg/d cariprazine group and from two weeks for the 3–6 mg/d cariprazine group.
Cariprazine is an orally active dopamine D3- preferring D3/D2 receptor partial agonist, which was originally discovered by Gedeon Richter. The drug is undergoing Phase II or III development as a treatment for schizophrenia, bipolar depression, and as an adjunct treatment for major depressive disorder.