Healthcare Industry News: DURECT
News Release - July 11, 2007
Patient Recruitment Completed for Pivotal Phase III Study of RemoxyClinical Results Expected Q4 2007
SOUTH SAN FRANCISCO, Calif. and BRISTOL, Tenn., July 11, 2007 (Healthcare Sales & Marketing Network) -- Pain Therapeutics, Inc. (NasdaqGM:PTIE ) and King Pharmaceuticals, Inc. (NYSE:KG ) announced today they have reached the enrollment target of 400 patients for a Phase III study with Remoxy(tm). Remoxy, an investigational drug, is a proprietary abuse-deterrent version of long-acting oxycodone, a strong opioid painkiller.
This randomized, double-blinded, placebo-controlled study enrolled patients in the U.S. with moderate-to-severe osteoarthritic pain. Following a titration period, patients were randomized to either twice-daily Remoxy (10-80 mg daily) or placebo for 12 weeks. The primary endpoint is change in pain scores during the treatment period. Top line results of this study are expected in Q4 2007, after the last patient completes the three-month treatment period.
This Remoxy study is being conducted under the auspices of a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA). The SPA specifies the Phase III trial objective, design, clinical endpoints and statistical analyses needed to support FDA 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 are evident. Under the SPA, one successful Phase III study is required to file a New Drug Application for Remoxy.
Remoxy, an investigational drug, is an abuse-deterrent version of long-acting oxycodone, a strong opioid painkiller. It is intended to meet the needs of physicians or pharmacists who appropriately prescribe or dispense long-acting opioids and who seek to minimize risks of diversion, abuse or misuse. Pain Therapeutics and King Pharmaceuticals have a strategic alliance in place to develop and commercialize Remoxy and other abuse-deterrent opioids. Remoxy's formulation includes Oradur(tm) technology licensed from DURECT Corporation (NasdaqGM:DRRX ).
About Oxycodone Abuse
Please visit the U.S. Drug Enforcement Administration's website for more information: http://www.deadiversion.usdoj.gov/drugs_concern/oxycodone/oxycodone.htm.
About Pain Therapeutics, Inc.
Pain Therapeutics develops novel drugs for pain management and hematology/oncology. The Company has four investigational drug candidates in clinical programs, including Remoxy, Oxytrex(tm), PTI-202 and a novel radio-labeled monoclonal antibody to treat metastatic melanoma. The FDA has not yet evaluated the merits, safety or efficacy of our drug candidates. For more information, please visit http://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 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 its drug candidates, including the expected top-line results of the Remoxy Phase III study, and the potential benefits of the Companies' 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 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. For further information regarding these and other risks related to the Companies' business, investors should consult the Companies' filings with the Securities and Exchange Commission.
Source: Pain Therapeutics
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