ORADUR®-Hydromorphone and ORADUR®-Oxymorphone

Overview

ORADUR-Hydromorphone and ORADUR-Oxymorphone are investigational opioid analgesics containing hydromorphone and oxymorphone, respectively. Based on DURECT's proprietary ORADUR technology, these drugs are under study to determine whether they can provide sustained pain relief while also deterring common methods of tampering associated with opioid misuse and abuse.

Hydromorphone and oxymorphone are currently available in immediate-release and extended-release forms. When taken as prescribed, they may allow individuals suffering from chronic pain to control their symptoms sufficiently to resume many of their daily activities.

Opioid medications expose users to the risks of addiction, abuse, and misuse, even when abuse-deterrent properties are present. ORADUR-Hydromorphone and ORADUR-Oxymorphone are investigational products and have not been approved by the FDA for marketing in the U.S. for any indication.

ORADUR-Hydromorphone and ORADUR-Oxymorphone are being studied for their ability to:

  • Permit twice-daily dosing
  • Provide long-term pain control
  • Deter the most common methods of abuse (snorting, smoking, injecting, chewing, and dissolving in drinks)

Opioid medications such as hydromorphone and oxymorphone expose users to the risks of addiction, abuse, and misuse even when abuse-deterrent properties are present. ORADUR-Hydromorphone and ORADUR-Oxymorphone are investigational products and have not been approved by the FDA for marketing in the U.S. for any indication.

Chronic pain affects as many as 100 million Americans annually. When chronic pain is severe, patients may be prescribed long-acting opioid analgesics such as hydromorphone and oxymorphone. In recent years, a dangerous increase in the misuse and abuse of this class of painkillers has created an urgent need for tamper-resistant opioid formulations.

Opioid medications expose users to the risks of addiction, abuse, and misuse even when abuse-deterrent properties are present. ORADUR-Hydromorphone and ORADUR-Oxymorphone are investigational products and have not been approved by the FDA for marketing in the U.S. for any indication.

Phase 1 clinical trials have been conducted for ORADUR-Hydromorphone, and an IND has been filed with the FDA for ORADUR-Oxymorphone.

DURECT currently holds the worldwide development and commercialization rights for ORADUR-Hydromorphone and ORADUR-Oxymorphone.

Learn more about ORADUR abuse-deterrent technology

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.