FDA issues Complete Response Letter for Pfizer's REMOXY NDA

DURECT Corporation (Nasdaq: DRRX) today reported that Pfizer Inc. (NYSE: PFE) has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for REMOXY®, a controlled-release form of oxycodone designed to discourage common methods of tampering.  Pfizer stated that it is working to evaluate the issues described in the Complete Response Letter and plans to have further discussions with FDA around them.

"Pfizer has an experienced team of scientists dedicated to resolving the remaining issues," stated James E. Brown, D.V.M., President and CEO of DURECT Corporation.  "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."