REMOXY®(ORADUR®-Oxycodone) ER capsules
The current opioid drug abuse epidemic is a critical public health matter. FDA has encouraged the development of abuse-deterrent opioid formulations to help combat this epidemic, consistent with its Guidance for Industry.
REMOXY ER is an investigational drug candidate containing oxycodone in extended-release capsules based on DURECT's ORADUR technology. It is being evaluated to determine whether it can deter 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 when abuse-deterrent properties are present. REMOXY ER is an investigational new drug and has not been approved 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.