REMOXY®(ORADUR®-Oxycodone) ER capsules

Overview

The current opioid drug abuse epidemic is a critical public health matter. FDA encourages the development of abuse-deterrent opioid formulations to help combat this opioid epidemic, consistent with the FDA’s Guidance for Industry.

REMOXY ER is an investigational drug candidate containing oxycodone in extended-release capsules based on DURECT’s ORADUR technology. It is designed to discourage common methods of tampering associated with opioid misuse and abuse.

Opioid drugs such as oxycodone expose users to risks of addiction, abuse and misuse even where abuse-deterrent properties exist. REMOXY ER is an investigational new drug not currently authorized by the FDA for marketing in the U.S. for any indication.

There are risks and uncertainties associated with our business. Please see our most recent SEC filings (10-K or 10-Q) for a complete description of these risks and uncertainties, which are incorporated herein by reference.