Janssen Research & Development, LLC (Janssen) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for three-month atypical antipsychotic paliperidone palmitate to treat schizophrenia in adults. If approved, it will be the first and only long-acting atypical antipsychotic that has a dosing schedule of just four times a year.

Priority Review is a designation for a drug that treats a serious condition and, if approved, would provide significant improvement in safety or effectiveness. A priority review designation means FDA’s goal is to take action on the marketing application within six months of receipt as compared to 10 months under standard review.

“If approved, this three-month formulation adds an unprecedented treatment option to help address the needs of people living with schizophrenia by providing a new, less frequently dosed treatment choice,” said Husseini K. Manji, M.D., Global Head, Neuroscience Therapeutic Area, Janssen Research & Development, LLC. "New treatments give patients, and caregivers, a broader range of options to address their needs as early as possible in their recovery journeys.”

For more details, go to: http://www.jnj.com/news/all/FDA-Grants-Priority-Review-for-Three-Month-Paliperidone-Palmitate-for-the-Treatment-of-Schizophrenia