Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson, announced that FDA approved their long-acting atypical antipsychotic Invega Hayfera (six-month paliperidone palmitate) for treatment of schizophrenia in adults. Paliperidone palmitate is the first twice-yearly injectable for the treatment of schizophrenia in adults approved by FDA, according to a company press release.

The FDA approval follows a 12-month, randomized, double-blind, non-inferiority Phase III study that enrolled 702 adults (ages 18–70) living with schizophrenia from 20 countries. According to the press release, results showed non-inferiority of paliperidone palmitate compared to Invega Trinza (paliperidone), the company’s three-month injectable antipsychotic, on the primary endpoint of time to first relapse at the end of the 12-month period.