Remoxy oxycodone: Development ongoing

Pfizer said it will conduct the additional clinical studies of Remoxy required to address a June 2011 complete response letter from FDA, including a study to compare bioequivalence of the modified and original formulations of Remoxy and an abuse-potential study. The pharma declined to provide a timeline for beginning the studies, but reiterated that it does not expect to submit a response to the Remoxy letter before mid-2015 (see BioCentury, Aug. 19). In May, Pfizer said it had not yet made a go/no-go decision on Remoxy but said there is "much to consider" given the delays and costs for the program and "development work left" in the program (see BioCentury, May 13). ...