Erzofri(Paliperidone palmitate ER)

Erzofri (Paliperidone palmitate ER) is a drug developed by Luye Innomind Pharma Shijiazhuang Co., Ltd. for the proposed indication of schizophrenia. The New Drug Application (NDA216352) for Erzofri was submitted on September 26, 2023, and received a Standard review designation, with a PDUFA Goal Date and Review Completion Date of July 26, 2024.

Efficacy findings indicate that a 156 mg deltoid injection of LY03010 resulted in a Cmax of 16.0 ng/mL, while a gluteal injection of the same dose yielded a Cmax of 11.2 ng/mL. The Cmax for the 156 mg deltoid injection was 43% higher than the gluteal injection. During the initial regimen period, LY03010 showed a Cmax of 43.7 ng/mL, a Ctrough of 28.5 ng/mL, and a Cavg of 30.3 ng/mL. At steady state, the Cmax-ss was 42.6 ng/mL and the Ctrough,ss was 28.3 ng/mL. The apparent volume of distribution for Paliperidone was 2840 L.

Safety data from the initial dosing regimen (IDR) phase reported an incidence of Extrapyramidal Symptoms (EPS) at 3.5%. In terms of Cmax exceeding 120 ng/mL, 2% of patients receiving LY03010 and 3% of patients receiving the loading dose (LD) experienced this. The observed maximum Cmax was 225 ng/mL for LY03010 and 194 ng/mL for LD. One participant experienced an orthostatic SBP decrease of >=20mmHg, and six participants experienced an orthostatic DBP decrease of >=10 mmHg.