REMOXY ER (extended-release oxycodone capsules CII) – REMOXY, our lead drug candidate, is a proprietary abuse-deterrent, twice-daily, oral oxycodone to treat severe chronic pain. T he REMOXY NDA was submitted to the FDA, with priority (six-month) review, in the first quarter of 2018 and was assigned a Prescription Drug User Fee Act ( “ PDUFA ” ) date of August 7, 2018 . The REMOXY NDA is requesting label claims against the injection, inhalation and nasal routes of abuse. The FDA held an Advisory Committee meeting (“Meeting”) on June 26, 2018 , to discuss the REMOXY NDA . At the conclusion of th e Meeting, members of the Advisory Committee voted 14 - to - 3 against regulatory approval of REMOXY ER. In addition, during the Meeting, the FDA expressed an opinion that current data for REMOXY ER may not support label claims against the injection and inhalation routes of abuse. At its sole discretion, the FDA may or may not follow the Advisory Committee’s recommendation. We own exclusive rights to develop and commercialize REMOXY worldwide, with a sales royalty obligation to one of our technology partners.
FENROCK ™ (transdermal fentanyl patch CII) – FENROCK is a proprietary, abuse-deterrent fentanyl skin patch to treat severe pain. This is an early-stage program that is substantially funded by a competitive research grant award from the NIDA, the primary agency of the U.S. government for research on drug abuse. We own exclusive, worldwide rights to FENROCK, with no royalty obligations to any third party.
PTI-125 – PTI-125 is a proprietary small molecule drug for the treatment of AD. In 201 8 , we completed a first-in-human Phase I study with PTI-125. This is an early-stage program that is substantially funded by competitive research grant awards from the NIH, the primary agency of the U.S. government for biomedical research. We own exclusive, worldwide rights to PTI-125, with no royalty obligations to any third party.
PTI-125DX – PTI-125 is a proprietary, blood-based diagnostic/biomarker to detect AD. This is an early -stage program that is substantially funded by competitive research grant awards from the NIH. We own exclusive, worldwide rights to PTI-125DX, with no royalty obligations to any third party.
Pain Therapeutics, Inc., a biopharmaceutical company, engages in the research and development of drugs for use in pain management, primarily in the area of opioid painkillers in the United States. Its Phase III clinical trial products include Remoxy, which is an anti-abuse version of long-acting oxycodone; and Oxytrex, which is an opioid painkiller for the treatment of chronic pain. The company has a strategic alliance with King Pharmaceuticals, Inc. for the development and commercialization of Remoxy and other abuse-resistant opioid painkillers. Pain Therapeutics was founded in 1998 and is based in South San Francisco, California.