FDA Approves First 3-Month Schizophrenia Treatment

The FDA today approved Janssen's 3-month paliperidone palmitate (Invega Trinza), an atypical antipsychotic to treat schizophrenia in adults.

Invega Trinza is the first and only FDA-approved schizophrenia medication administered just 4 times a year. Janssen initially submitted the New Drug Application for a 3-month formulation of its 1-month paliperidone palmitate (Invega Sustenna) schizophrenia treatment in November 2014, and the FDA granted it priority review designation in January 2015.

Before starting Invega Trinza, patients must be adequately treated with Invega Sustenna for at least 4 months.

“With a dosing interval that can be measured in seasons, not days, people living with schizophrenia and their treatment teams can focus on recovery goals beyond short-term symptom control,” said Invega Trinza trial investigator Joseph Kwentus, MD, in a press release. “Recovery looks different for everyone, and the long-term symptom control offered by Invega Trinza can help patients work toward their own personal goals.”

The FDA based its nod on the results of a phase 3 long-term maintenance trial in which 93% of patients treated with Invega Trinza did not experience a significant return of schizophrenia symptoms. The drug’s safety and tolerability were also found to be consistent with those of Invega Sustenna, and the study raised no new risk-benefit concerns.

“It's encouraging to see continued progress in the treatment of schizophrenia, since access to a range of treatment options is a critical success factor in the treatment journey of individuals living with this disease,” stated Mental Health America president and CEO Paul Gionfriddo. “As both an advocate and a parent of an adult son with schizophrenia, I can attest to the importance of novel therapies that enable our loved ones to spend more time focusing on their recovery and less time worrying about taking medications.”

Janssen plans to launch Invega Trinza by mid-June, according to a press release.