Pain Therapeutics And King Pharmaceuticals®, Inc. Initiate Clinical Program Of A Second Abuse-Resistant Painkiller; Triggers $5 Million Milestone Payment
Drug Name Description Clinical Status Remoxy(TM) Abuse-resistant oxycodone Phase III PTI-202 Abuse-resistant opioid (undisclosed) Phase I
PTI-202 is a long-acting opioid painkiller. Pain Therapeutics and King Pharmaceuticals have not yet disclosed the active pharmaceutical drug in PTI-202.
Pain Therapeutics recently submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for PTI-202. FDA acceptance of this IND triggered the payment of a $5 million cash milestone from King Pharmaceuticals to Pain Therapeutics.
About Remoxy
Remoxy is being developed as an abuse-resistant version of long-acting oxycodone. Its Phase III program remains on-track with previous guidance. Remoxy is intended to meet the needs of physicians who appropriately prescribe opioid painkillers and who seek to minimize risks of drug diversion, abuse or accidental patient misuse. Remoxy has a sticky, high-viscosity mass that resists injection or snorting. Published data show that freezing, crushing or submerging Remoxy in high-proof alcohol for hours at a time releases just a fraction of oxycodone compared to Oxycontin® at time points when abusers presumably expect to get high. Pain Therapeutics and King Pharmaceuticals believe these and other physical properties of Remoxy may deter recreational abuse or accidental patient misuse of long acting oxycodone.
About Pain Therapeutics, Inc.
Pain Therapeutics is a biopharmaceutical company that develops novel drugs. We have three investigational drug candidates in clinical programs. Remoxy and PTI-202 are proprietary, abuse-resistant forms of currently prescribed opioid drugs. Oxytrex(TM) is a novel, next-generation painkiller that potentially offers less physical dependence than currently marketed opioid painkillers. These three drugs target different segments of the multi-billion dollar market to treat severe chronic pain, such as persistent low-back pain or pain due to advanced stages of osteoarthritis. The FDA has not yet evaluated the merits, safety or efficacy of our drug candidates. For more information, please consult our website: www.paintrials.com .
About King Pharmaceuticals, Inc.
King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products in attractive markets and the strategic acquisition of branded products that can benefit from focused promotion and marketing and product life-cycle management.
Note Regarding Forward-Looking Statements: This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Pain Therapeutics disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, any statements relating to the timing of the completion of the Pain Therapeutics' (the "Company") Phase I clinical trial for PTI-202 and announcement of results from such clinical trial, the Company's guidance with respect to the clinical trials program for Remoxy, and the potential benefits of the Company's drug candidates. Such statements are based on management's current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of the Company's drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates that could slow or prevent product approval or market acceptance (including the risk that current and past results of clinical trials are not necessarily indicative of future results of clinical trials), and the uncertainty of patent protection for the Company's intellectual property or trade secrets. For further information regarding these and other risks related to Pain Therapeutics' business, investors should consult the Company's filings with the Securities and Exchange Commission.
Source: Pain Therapeutics, Inc.