Janssen announced that the Food and Drug Administration (FDA) has approved Invega Trinza (paliperidone palmitate) extended-release injectable suspension, the first and only medication indicated for the treatment of schizophrenia in adults that requires administration only four times per year and provides the longest dosing interval currently available.
Invega Trinza, an atypical antipsychotic, utilizes Alkermes’ proprietary NanoCrystal technology that enables solubility of poorly water-soluble compounds. Prior to initiating treatment, patients must be adequately treated with monthly Invega Sustenna (paliperidone palmitate) for injection for at least four months.
The approval was based on a Phase 3 study, published in JAMA Psychiatry, which demonstrated that 93% of patients treated with Invega Trinza did not experience a significant return of schizophrenia symptoms. The safety and efficacy was consistent with that of Invega Sustenna in this long-term maintenance trial.
Invega Trinza was granted Priority Review by the FDA in January 2015. It is anticipated to launch in mid-June 2015 in 273mg, 410mg, 546mg, and 819mg extended-release injectable suspension strengths for intramuscular use.
For more information visit InvegaTrinzaHCP.com.