Indivior PLC said the U.S. Food and Drug Administration approved Perseris, a once-monthly injectable that contains risperidone, for adults with schizophrenia.

Risperidone is an established treatment for schizophrenia, a serious mental disorder that affects a patient's thoughts, emotions and behavior.

Perseris provides patients sustained levels of risperidone over one month via an extended-release delivery system.

The Richmond, Va.-based drugmaker's application was backed by late-stage trial data demonstrating Perseris' efficacy, even without a loading dose or any supplemental oral risperidone.