FDA issues CRL for Pfizer Remoxy NDA

Remoxy, which is based on Durect’s Oradur technology, is an experimental drug that is a controlled release formulation of oxycodone for moderate-to-severe chronic pain designed to reduce potential risks of unintended use.

Pfizer is currently working to assess the issues raised by the FDA and, intends to discuss and resolve the issues with the agency soon.

Durect president and CEO James Brown said Pfizer has an experienced team of scientists dedicated to resolving the remaining issues.

"The misuse and abuse of pain medications is a widespread problem in this country and we will continue to support Pfizer in their efforts to address this important public health and safety issue," Brown said.