Forest Laboratories, Inc and Gedeon Richter today announced positive top-line results from a Phase IIb clinical trial of the novel, investigational antipsychotic agent cariprazine for the treatment of acute exacerbation of schizophrenia.
Based on the latest data, subject to a complete review of the full results, and the previously announced phase II results in patients suffering from acute mania associated with bipolar I disorder, the companies intend to initiate phase 3 trials for both indications in early 2010.
Cariprazine is currently also undergoing phase II clinical trials in patients with bipolar depressive disorder and as adjunctive therapy in major depressive disorder.
Cariprazine was discovered by researchers at Gedeon Richter and licensed in the United States and Canada by Forest Laboratories in 2004.
“We are very encouraged by these results as we believe that cariprazine has the potential to be
a valuable new treatment option for people suffering from schizophrenia. These results are
considered as a further step towards our commitment conducting original research in the field
of CNS disorders, where our team has excellent expertise,” said Erik Bogsch, Chief Executive
Officer, Gedeon Richter Plc. (MTI-ECONEWS)