SOUTH SAN FRANCISCO, Calif., March 15 /PRNewswire-FirstCall/ -- Pain Therapeutics, Inc. today announced it will present results from prior Phase III studies evaluating the safety, efficacy and minimal physical dependence of Oxytrex. These data will be presented at the 25th Annual Scientific Meeting of the American Pain Society on May 4-5th in San Antonio, Texas.
“These collective results support the ongoing development program for Oxytrex, which we believe remains on-track to advance into a Phase III pivotal program in the second half of 2006,” said Nadav Friedmann, PhD, MD, chief operating and medical officer of Pain Therapeutics.
Oxytrex, an investigational drug, is a strong opioid painkiller with minimal physical dependence. It is intended for patients with severe chronic pain. The Company is in strategic discussions with the FDA regarding the design of a pivotal Phase III program for Oxytrex.
“The idea of developing a strong opioid painkiller with minimal physical dependence is something of a holy grail in pain management,” said Remi Barbier, Pain Therapeutics’ president and chief executive officer. “As a science driven company, we’re delighted to have been invited to present our data in this peer-reviewed forum.”
Data Abstracts
Pain Therapeutics will present a series of science poster presentations at the 25th Annual Scientific Meeting of the American Pain Society on May 4-5th in San Antonio, Texas, including:
“Oxytrex Has Minimal Physical Dependence and Improved Safety vs. Oxycodone in Phase III Clinical Trial in Low-back Pain” and “Phase III Study To Assess Physical Dependence and Analgesic Efficacy of Oxytrex Versus Oxycodone”
The first poster presents detailed results of a previously announced Phase III study with Oxytrex in 719 patients with severe chronic low-back pain. Oxytrex patients reported 56% less physical dependence (p=0.01) after cessation of prolonged, high-dose opioid therapy compared to patients on oxycodone. Oxytrex patients reported equal pain relief to patients on oxycodone, despite significantly lower drug use (p=0.03) and less opioid- related side-effects during treatment, including 33% less somnolence (p=0.03), 51% less pruritus (p<0.001) and 44% less moderate-to-severe constipation (p=0.01).
The second poster presents detailed results of a previously announced Phase III study with Oxytrex in 775 patients with severe osteoarthritic pain. Despite a high (51%) overall drop out rate in this study, Oxytrex reduced physical dependence by 22% compared to an equivalent dose of oxycodone. In
patients over 50 years of age, Oxytrex reduced physical dependence by 43% (p=0.042).
The Company’s academic collaborators will also present positive pre-clinical data on a variant of Oxytrex to treat neuropathic pain. In addition, Pain Therapeutics will present previously announced positive Phase III data on Remoxy(TM).
All posters will be made available on May 4, 2006 on Pain Therapeutics’ website, www.paintrials.com and may be available sooner on the website of the American Pain Society, www.ampainsoc.org.
About Pain Therapeutics, Inc.
Pain Therapeutics is a biopharmaceutical company that develops novel drugs. We have two investigational drug candidates, Remoxy and Oxytrex, 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.
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”). PTI 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, scope or expected outcome of the Company’s clinical development of its drug candidates, the potential benefits of the Company’s drug candidates and the size of the potential market for the Company’s products. 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), the uncertainty of patent protection for the Company’s intellectual property or trade secrets, the Company’s 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 Company’s 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 cwaarich@paintrials.com; or press,Carney Duntsch of Burns McClellan, +1-212-213-0006, for Pain Therapeutics,Inc.
Web site: http://www.paintrials.com//
