The FDA has approved under Priority Review Janssen Pharmaceuticals’ New Drug Application (NDA) for the three-month long-acting atypical antipsychotic Invega Trinza. Invega Trinza, a three-month injection, is an atypical antipsychotic indicated to treat schizophrenia. Before starting Invega Trinza, patients must be adequately treated with Invega Sustenna (one-month paliperidone palmitate) for at least four months. Priority Review is a designation for drugs that, if approved, would offer significant improvement in the treatment of serious conditions.
In a long-term maintenance trial, 93% of patients treated with Invega Trinza did not experience a significant return of schizophrenia symptoms. Based on positive efficacy, Janssen concluded this study early following the recommendation of an Independent Data Monitoring Committee (IDMC).
"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 trial investigator Joseph Kwentus, M.D., Precise Research Centers. "Recovery looks different for everyone, and the long-term symptom control offered by Invega Trinza can help patients work toward their own personal goals."
Schizophrenia is a complex and chronic brain disorder in which symptoms can be severe and disabling and can affect all aspects of a person's daily life. With this new treatment option, healthcare providers can give patients greater independence by enabling them to focus less on taking their medication and more on other aspects of their treatment plan.
"Building on Janssen's more than 50 years of leadership in developing innovative mental health therapies and helpful programs, this medication offers a new paradigm for treating people living with schizophrenia," said Husseini Manji, M.D., global head, neuroscience therapeutic area, Janssen Research & Development. "After at least four months on Invega Sustenna, patients and their doctors can seamlessly transition to Invega Trinza for sustained symptom control with a single dose every three months."
Janssen anticipates that Invega Trinza 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," said Paul Gionfriddo, president and CEO, Mental Health America.
"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."
Based on the phase III study, the safety and tolerability profile of Invega Trinza is consistent with that of Invega Sustenna. No new benefit-risk concerns emerged from studies of Invega Trinza. The safety and tolerability of paliperidone has been established in multiple formulations across many clinical trials. Invega Trinza utilizes Alkermes' proprietary NanoCrystal technology, which enables solubility of poorly water-soluble compounds.
Schizophrenia affects approximately 2.4 million U.S. adults, often beginning in early adulthood, just as individuals are establishing their independence. The course of schizophrenia is varied, frequently involving periodic relapses of the disease with sometimes incomplete response to treatment. Each relapse can result in reduced response to treatment, putting continued symptom control even further out of reach.