Based on DURECT’s ORADUR technology, REMOXY is a unique long-acting formulation of oxycodone designed to discourage common methods of tampering associated with opioid misuse and abuse. It is intended for patients with moderate-to-severe chronic pain.
When taken as prescribed, opioid analgesics allows individuals suffering from chronic pain to sufficiently control their pain and resume many of their daily activities. However, this class of drugs may be abused, misused, and diverted, which has led to a major public healthcare crisis.
- Effective long-term pain control with the convenience of twice-daily dosing
- Proprietary formulation with several properties designed to deter abuse by the most common methods (snorting, smoking, injecting, chewing, and dissolving in drinks)
Chronic pain affects as many as 100 million Americans annually. When chronic pain is severe enough, patients are frequently prescribed long-acting opioid analgesics. Opioids (also called narcotics) include oxycodone, hydrocodone, hydromorphone, oxymorphone, morphine, fentanyl, methadone, and other members of this class. OxyContin®, a brand name oral extended-release oxycodone-based painkiller, accounted for approximately $2.4 billion in worldwide sales in 2014.
In March 2016, Pain Therapeutics resubmitted the NDA for REMOXY. In April 2016, the FDA deemed the NDA sufficiently complete to permit a substantive review, and stated that September 25, 2016 would be the target action date under the Prescription Drug User Fee Act (PDUFA). In May 2016, Pain Therapeutics disclosed that an Advisory Committee of the FDA will review the REMOXY NDA in a meeting tentatively scheduled for August 5, 2016 and that the FDA had advised Pain Therapeutics that the PDUFA date for the REMOXY NDA, September 25, 2016, will remain unchanged.
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.