Janssen studies higher initiation dose for paliperidone palmitate
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
J&J's Janssen unit is conducting an additional Phase III trial of paliperidone palmitate to further assess a 150 mg equivalent initiation dose of the injectable long-acting form of Invega (paliperidone) for treatment of schizophrenia. The firm announced results of a 13-week study Dec. 10 showing paliperidone palmitate to have a statistically significant symptom control compared to placebo at all doses tested when given every 4 weeks for 13 weeks with a 150 mg eq. initiation dose. Subsequent doses were either 25 mg, 100 mg, or 150 mg eq. An earlier dose-ranging trial using a much lower initiation dose of 50 mg eq. failed to show non-inferiority to risperidone LAT. J&J said Oct. 14 that the drug's launch might have to be pushed back to 2010 to address an FDA "complete response" requesting a re-analysis of a subset of the data (1Pharmaceutical Approvals Monthly September 2008, p. 16)