Forest Laboratories files cariprazine NDA for two indications
Forest Laboratories has submitted an NDA to the FDA for cariprazine, an orally active and potent dopamine D3-preferring D3/D2 receptor partial agonist. Cariprazine was discovered by Hungary-based Gedeon Richter and is licensed to Forest Laboratories in the US and Canada.
The application for the treatment of schizophrenia includes results from three positive trials in over 1,700 patients, two fixed dose studies with active controls and one fixed flexible placebo-controlled dose study using the change from baseline in Positive and Negative Syndrome Scale (PANSS) total score as primary efficacy endpoint. The application for the acute treatment of manic or mixed episodes associated with bipolar I disorder includes results from three positive placebo-controlled trials in over 1,000 patients, two flexible dose studies and one fixed flexible-dose study using the change from baseline in the Young Mania Rating Scale (YMRS) total score as primary efficacy endpoint.
In the schizophrenia and bipolar mania pivotal trials, cariprazine was generally well tolerated. The most commonly reported adverse reactions (>= 5 per cent and twice placebo), which were predominantly mild-to-moderate in severity, were akathisia, extrapyramidal disorder, dyspepsia, restlessness, tremor, fatigue and vomiting.