Pain Therapeutics, Inc., a biopharmaceutical company, is engaged in the development of novel drugs. REMOXY The company’s major drug candidate, REMOXY, is an extended-release oral formulation of oxycodone for the management of moderate-to-severe pain when a continuous opioid analgesic is needed for an extended period of time. REMOXY is a novel controlled-release oral capsule form of oxycodone in a highly viscous liquid formulation matrix that includes novel excipients. It is primarily formulated to help address issues of abuse and misuse of time-release oxycodone tablets. The company designed REMOXY to discourage common methods of tampering and misuse. The REMOXY formulation is designed to resist common methods of chemical or physical manipulation. REMOXY’s capsule dosage form provides therapeutic drug levels of oxycodone on a twice-daily dosing schedule, while resisting the rapid increases in plasma levels of oxycodone associated with common methods of abuse and misuse. Its formulation also resists delivery by unapproved routes of administration, such as injection, snorting, or inhalation. REMOXY is an investigational drug candidate whose safety and efficacy have not yet been established by the U.S. Food and Drug Administration (FDA). REMOXY is intended to meet the needs of physicians who appropriately prescribe opioid painkillers and who seek to minimize the risks of drug diversion, abuse or accidental patient misuse, as well as the needs of pharmacists and the managed care healthcare system in the United States. REMOXY is being developed pursuant to a strategic alliance that the company has with Pfizer, Inc. (Pfizer) under the Pfizer agreements. The company and King Pharmaceuticals, Inc. jointly managed a Phase III clinical program and NDA submission for REMOXY. Abuse-resistant Formulations of Hydromorphone, Hydrocodone, and Oxymorphone The company’s abuse-resistant product candidates are intended to meet the needs of physicians who appropriately prescribe opioid painkillers and who seek to minimize the risks of drug diversion, abuse or accidental patient misuse, as well as the needs of pharmacists and the managed care healthcare system in the United States. Investigational New Drug applications for all three drug candidates are in place with FDA. Early-stage Product Candidates The company continues to develop early-stage novel product candidates. It owns all commercial rights to these early-stage product candidates. Agreements The company has an exclusive, worldwide development and license agreement with Durect Corporation to use a patented technology that forms the basis for certain drug candidates, including REMOXY. Strategy Elements of the company’s strategy include focusing on clinical development stage products; retaining significant rights to its drugs; outsourcing major functions; and pursuing in-licensing or acquisition opportunities. Intellectual Property The company’s material patents and the material patents that the company licenses from third parties include various issued U.S. Patents, such as 8,420,120; 8,415,401; 8,354,124; 8,168,217; 8,153,152; 8,147,870; 8,133,507; 7,833,543; 6,413,536; 5,968,542; and 5,747,058. Its issued U.S. patents and the issued U.S. patents that the company licenses from third parties for REMOXY are estimated to expire by 2031. In Europe, the granted patents for REMOXY are estimated to expire by 2023. REMOXY is a trademark of the company. Significant Events Pfizer Inc. has notified Pain Therapeutics Inc. that it has decided to discontinue its agreement to develop and commercialize REMOXY (oxycodone) Extended-Release Capsules CII, an investigational extended-release oral formulation of oxycodone. History Pain Therapeutics, Inc. was founded in 1998. The company was incorporated in Delaware in 1998.
pain therapeutics inc (PTIE:NASDAQ GS)
7801 North Capital of Texas Highway
Austin, TX 78731
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