Investigational Antipsychotic Shows Promise in Schizophrenia

Caroline Cassels

February 28, 2012

February 28, 2012 — Topline results from 2 phase III trials of RGH-188 (cariprazine, Forest Laboratories Inc, Gedeon Richter Plc), an investigational antipsychotic, suggest that the drug may be effective for the treatment of acute exacerbation of schizophrenia.

The data in both trials show that compared with placebo, patients treated with the agent experienced significant symptom improvement, as measured by the Positive and Negative Syndrome Scale.

All doses showed statistically significant separation from placebo starting at week 2 and at each subsequent time point, with the higher dose showing separation as early as week 1 of treatment.

The results of these 2 studies are consistent with the results of the previously completed placebo-controlled phase IIb fixed-dose study in this population, the manufacturers report.

"We are pleased with these results which demonstrate that cariprazine provided significant improvement in symptoms for patients suffering from schizophrenia," Zsolt Szombathelyi, MD, research director of Gedeon Richter Plc, said in a statement.

According to the statement, the drug is also being investigated in clinical studies for patients with bipolar depression and as an adjunctive treatment for major depressive disorder.

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