South San Francisco, Calif. - October 3, 2000 - Pain Therapeutics, Inc. (Nasdaq: PTIE), a developer of next generation opioid painkillers, today announced positive safety and efficacy results from a Phase II dose-ranging study evaluating PTI-701, one of the Company's investigational new drugs for the treatment of pain.
The randomized, double blind, placebo and active controlled Phase II study was conducted in 300 patients experiencing moderate to severe pain following oral surgery. The study assessed the safety and analgesic efficacy of a single dose of PTI-701 compared to either placebo or a standard dose of 5 mg hydrocodone/500 mg acetaminophen following third molar extraction.
"Despite the widespread clinical use of opioid painkillers, pain management remains less than optimal," said Barry Sherman, M.D., executive vice president and chief medical officer. "Our results indicate that PTI-701 is effective and offers patients better pain relief over hydrocodone in a surgical model of pain. We are also encouraged that these Phase II results are remarkably consistent with our earlier studies comparing other PTI drugs against morphine and tramadol."
Results from the clinical study demonstrated that PTI-701 provided patients with statistically better pain relief than placebo (p<0.001) during the effective treatment period. Patients treated with PTI-701 achieved 29% more pain relief compared to patients treated with 5 mg hydrocodone/500 mg acetaminophen. This result was also statistically significant (p<0.046). These positive findings were supported by improvements in peak pain relief, patients' global pain assessments and other standard measurements of analgesic efficacy. Moreover, the incidence of common opioid related side effects was statistically similar among patients treated with PTI-701 or 5 mg hydrocodone/500 mg acetaminophen.
"We are very pleased with these clinical results and are encouraged that PTI-701 may represent an important new treatment option for patients in pain," said Remi Barbier, president and chief executive officer. "We think a drug that delivers better pain relief without increasing side-effects has a definite place in the $2 billion U.S. market for opioid painkillers."
About Pain Therapeutics, Inc.
Pain Therapeutics, Inc. is an emerging leader in the area of pain management. The Company is developing a new generation of proprietary painkillers that addresses the deficiencies of morphine, hydrocodone and other opioid painkillers that are widely used in clinical medicine. The Company is currently in late Phase II clinical trials with four proprietary painkillers. Pain Therapeutics has headquarters in South San Francisco, California and is traded on Nasdaq under the symbol PTIE. Visit www.paintrials.com for additional information on Pain Therapeutics.
The press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to the Company's clinical development program, or any drug candidate and any other statements that are not historical facts. 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 (including the risk that current 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 and the Company's ability to obtain additional financing if necessary. Such statements are based on management's current expectations, but actual results may differ materially due to various factors, including those risks and uncertainties mentioned or referenced in this press release. Examples of such statements include statements about potential market for our products.