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FDA grants priority review to 3-month paliperidone palmitate
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The FDA has granted priority review status for the new drug application for Janssen’s three-month atypical antipsychotic, paliperidone palmitate, for the treatment of schizophrenia, according to a press release.
“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,” Husseini K. Manji, MD, global head of the neuroscience therapeutic area at Janssen, said in the press release. “New treatments give patients, and caregivers, a broader range of options to address their needs as early as possible in their recovery journeys.”
The priority review was given based on phase 3 data that evaluated the efficacy of the 3-month treatment vs. placebo. The study was stopped early for positive outcomes, according to the press release.
The drug’s safety is consistent with once monthly paliperidone palmitate (Invega Sustenna, Janssen), approved by the FDA in July 2009.