FDA approves Invega Trinza under priority review for schizophrenia

Janssen Pharmaceuticals announced today the FDA has approved Invega Trinza, a three-month long-acting atypical antipsychotic, under priority review for the New Drug Application for treatment of schizophrenia.

In a longitudinal maintenance trial, 93% of patients who received Invega Trinza (3-month palperidone palmitate) did not experience a significant return of schizophrenia symptoms. The phase 3 study findings indicated the 3-month palperidone palmitate had comparable safety and tolerability to Invega Sustenna (1-month paliperidone palmitate, Janssen Pharmaceuticals).

The newly approved treatment, which is administered four times per year, uses technology that enables solubility of poorly water-soluble compounds.

Patients who receive 3-month paliperidone palmitate must be adequately treated with 1-month palperidone palmitate for at least 4 months prior.

“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,” study researcher Joseph Kwentus, MD, of Precise Research Centers, said 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.”

Janssen expects the 3-month paliperidone palmitate will be commercially available by mid-June.

“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,” Paul Gionfriddo, president and CEO of Mental Health America, said in the release.