BioCentury
ARTICLE | Clinical News

Remoxy oxycodone: Phase I start

August 19, 2013 7:00 AM UTC

Pfizer registered on clinicaltrials.gov an open-label, 3-way crossover Phase I trial to compare 40 mg Remoxy oxycodone vs. the original oxycodone formulation in about 18 healthy volunteers. Pfizer said the study is required for Remoxy's development but does not mean the pharma has made a decision on the program.

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. Pfizer also said it did not expect it would be able to submit a response to a June 2011 complete response letter before mid-2015. The pharma declined to comment on when it expects to make a decision on the Remoxy development program (see BioCentury, May 13). ...