Gedeon Richter and Actavis have unveiled positive results from a Phase III trial assessing the previously rejected cariprazine in preventing relapse in schizophrenia.
The 101-patient study met its primary endpoint, showing that cariprazine treatment was associated with a 55% reduction in risk of relapse versus placebo.
Cariprazine is a potent dopamine D3/D2 receptor partial agonist atypical antipsychotic in development for the treatment of patients with schizophrenia and for adults with manic or mixed episodes associated with bipolar I disorder.
In 2013, the US Food and Drug Administration rejected the drug calling for more trial data, even though the Agency noted at the time that it ‘clearly demonstrated effectiveness’.
