Pain Therapeutics And King Pharmaceuticals®, Inc. Receive Special Protocol Assessment For Remoxy(TM) And Commence Pivotal Phase III
SOUTH SAN FRANCISCO, Calif. and BRISTOL, Tenn., Feb. 16 /PRNewswire-FirstCall/ -- Pain Therapeutics, Inc. and King Pharmaceuticals, Inc. today announced that Remoxy has successfully completed a Special Protocol Assessment with the U.S. Food and Drug Administration (FDA). As a result, the companies are commencing a pivotal Phase III trial with Remoxy in 400 patients with severe chronic pain.
Remoxy, an investigational drug, is an abuse-resistant version of long-acting oxycodone, a strong opioid painkiller. Remoxy is intended to meet the needs of physicians who appropriately prescribe oxycodone and who seek to minimize risks of drug diversion, abuse or accidental patient misuse. Pain Therapeutics and King Pharmaceuticals have a strategic alliance in place to develop and commercialize Remoxy and other abuse-resistant opioids.
"We are delighted to have reached agreement with the FDA on a Phase III design for Remoxy," said Nadav Friedmann, PhD, MD, chief medical and operating officer of Pain Therapeutics. "We believe this pivotal trial features achievable endpoints, addresses patient drop-out issues and provides a clear path towards product approval."
Special Protocol Assessment
A Special Protocol Assessment (SPA) from the FDA specifies the Phase III trial objective, design, clinical endpoints and analyses needed to support regulatory approval. These features are considered binding, i.e., the FDA will not later alter its perspective unless public health concerns unrecognized at the time of protocol assessment under this process are evident. For more information please visit the FDA website: www.fda.gov/CbER/gdlns/protocol.pdf .
Phase III Trial Details
Under the terms of the SPA for Remoxy one pivotal Phase III trial is required to file a New Drug Application. The randomized, double-blinded, placebo-controlled, multi-center pivotal trial will enroll 400 patients with moderate-to-severe osteoarthritic pain in multiple U.S. clinical sites. Following a titration period, patients will be randomized to either Remoxy (10-80 mg daily) or placebo for 12 weeks. The primary endpoint is reduction in pain scores over three months compared to baseline. Patient accrual is expected to begin shortly and continue through year end 2006.
Remoxy is an abuse-resistant version of long-acting oxycodone. Remoxy's sticky, high-viscosity mass resists injection or snorting. Published data show that freezing, crushing or submerging Remoxy in high-proof alcohol releases just a fraction of oxycodone compared to Oxycontin(R) at time points when abusers presumably expect to get high. These physical properties of Remoxy are intended to deter recreational abuse or accidental patient misuse of long-acting oxycodone. The FDA has not yet evaluated the merits, safety or efficacy of Remoxy.
About Pain Therapeutics, Inc.
Pain Therapeutics is a biopharmaceutical company that develops novel drugs. The Company has two investigational drug candidates, Remoxy and Oxytrex(TM) in Phase III clinical programs. Both 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. For more information, please visit www.paintrials.com.
About King Pharmaceuticals, Inc.
King, an S&P 500 Index Company, is a vertically integrated branded pharmaceutical company that employs over 2,500 people. King's growing line of branded products includes neuroscience drugs such as Skelaxin(R) (metaxalone) and Sonata(R) (zaleplon).
King seeks to capitalize on opportunities in the pharmaceutical industry through internal development efforts, in-licensing arrangements or the acquisition of novel branded prescription drugs in attractive markets that can benefit from focused promotion, superior marketing or life-cycle management. For more information, please visit its website (www.kingpharm.com).
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 and King Pharmaceuticals disclaim any intent or obligation to update these forward-looking statements, and claim 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, scope or expected outcome of the companies' clinical development of Remoxy or its regulatory approval, the potential benefits of Remoxy and the companies' drug candidates and the size of the potential market for the companies' products, including Remoxy. Such statements are based on managements' 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 companies' drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the companies' 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), the uncertainty of patent protection for the companies' intellectual property or trade secrets, the companies' ability to obtain additional financing if necessary and unanticipated research and development and other costs. Other important factors that may cause actual results to differ materially from the forward-looking statements are discussed in the "Risk Factors" section and other sections of King's Form 10-K for the year ended December 31, 2004 and Form 10-Q for the third quarter ended September 30, 2005. 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.Pain Therapeutics, Inc.
CONTACT: Christi Waarich, Senior Manager of Investor Relations of PainTherapeutics, Inc., +1-650-825-3324, or email@example.com; or media,Carney Duntsch of Burns McClellan , +1-212-213-0006, for Pain Therapeutics,Inc.; or James E. Green, Executive Vice President, Corporate Affairs,+1-423-989-8125, or David E. Robinson, Senior Director, Corporate Affairs,+1-423-989-7045, both for King Pharmaceuticals, Inc.