Invega Sustenna was previously approved for acute and maintenance therapy for schizophrenia
The US Food and Drug Administration (US FDA) has approved Johnson and Johnson's atypical long-acting antipsychotic paliperidone palmitate (Invega Sustenna, Janssen Pharmaceuticals,) for schizo-affective disorder, either as once-monthly monotherapy or as an adjunctive treatment.
The approval was based on trial data that showed the drug was being significantly more effective than placebo in delaying relapse because of mood and psychotic symptoms. The drug was previously approved for acute and maintenance therapy for schizophrenia.
"Clinicians often find themselves taking a complicated approach using multiple medications to address schizoaffective disorder symptoms because widely accepted guidelines for the treatment of the condition are not available. The approval of an effective once-monthly medication that can be used as monotherapy or adjunctive therapy to manage the symptoms associated with schizoaffective disorder has the potential to change that approach," said Mr David P Walling, study lead investigator and chief executive and clinical officer, Collaborative NeuroScience Network.