Trevicta(previously Paliperidone Janssen)

Trevicta (previously Paliperidone Janssen) is a medication for which an application was submitted on 7 August 2014, receiving a CHMP positive opinion on 23 October 2014. The Marketing Authorisation for Xeplion, a related formulation, was granted on 4 March 2011. Regulatory documents include RMP version 5.1, approved on 23 May 2014, and RMP version 5.2, issued on 2 September 2014.

Efficacy studies, such as PSY-3011, evaluated the efficacy of XEPLION in delaying relapse of symptoms of schizoaffective disorder. In study PSY-3011, the percentage of subjects experiencing relapse was 8.1% in the PP3M group and 9.2% in the PP1M group. The lower bound of the 95% CI for the difference in relapse-free percentage between PP3M and PP1M was -2.7%. The pre-specified non-inferiority margin for PSY-3011 was -15%. The percentage of subjects completing the study without relapse was 75% in the PP3M group and 74% in the PP1M group.

Identified safety risks include Rhabdomyolysis, with potential risks such as Gastrointestinal obstruction (INVEGA only) and Decreased bone mineral density/Osteoporosis also noted. Discontinuation due to adverse events was 2.5%, and akathisia incidence was 4%. A shift from normal to low HDL cholesterol (≥40 to <40 mg/dL) was observed in 15.8% of subjects, and an increase in total cholesterol in 1.4%.