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)
You may also be interested in...
J&J's Paliperidone Gets "Complete Response" Letter From FDA
No more studies are required, but FDA outlined questions that need to be addressed, according to J&J
California Court’s Inaction On TiO2 Prop 65 First Amendment Case Breeds New Lawsuits
The Personal Care Products Council seeks to stem the rising tide of titanium dioxide Proposition 65 lawsuits, requesting that a California court prohibit the state’s Attorney General and private enforcers from filing and/or prosecuting new suits against cosmetics companies failing to warn about potential TiO2 exposure.
Kenvue Breaks Ground On New Headquarters, Appoints Chief Corporate Affairs Officer
Firm hosts groundbreaking for 290,000 square-foot global headquarters it’s having built in Summit, NJ, starting with 100,000 square-foot science and innovation and expected to open in 2025. It announced adding Russell Dyer as chief corporate affairs officer starting 13 March.