San Francisco, Calif., Dec. 11

Novel Painkiller

Pain Therapeutics Announces
Positive Phase I/II Clinical Results
With Novel Painkiller

PRNewswire/ Pain Therapeutics, Inc.

A medical research company, today announced positive Phase I/II results with PTI-801, a novel narcotic painkiller. The Company believes PTI-801 is a safer version of immediate release oxycodone, a widely prescribed narcotic painkiller. Last year, over $1 billion of oxycodone was sold in the U.S.

"Our vision for PTI-801 is simply to develop a safer version of a blockbuster drug," said Remi Barbier, president and chief executive officer of Pain Therapeutics. "We think the tremendous clinical and commercial appeal of this drug candidate will become more apparent as additional data is generated."

The Phase I/II studies were designed by Pain Therapeutics to analyze the safety and pharmacokinetic properties of PTI-801 by oral administration. Twenty-two human volunteers or patients with chronic, moderate to severe pain participated. No treatment-related or unexpected adverse events were noted in these studies. Results from these studies indicate that PTI-801 is a viable drug candidate that is well-tolerated in human volunteers and patients with chronic pain.

"We believe PTI-801 will represent a new class of drugs to treat pain," said Nadav Friedmann, Ph.D., and M.D., chief operating officer of Pain Therapeutics. "Due to a unique mechanism of action, we believe PTI-801 can minimize the opioid tolerance, dependence or addiction that is often associated with repeat use of oxycodone.

Based on this understanding, we now have in place a well thought out clinical development plan for PTI-801. This includes initiating a multi-dose safety study, followed by larger studies designed to provide compelling evidence of the drug's efficacy in chronic pain populations."

About Opioid Painkillers

Opioid painkillers are a $3 billion market in the United States and account for over five percent of all drug prescriptions. Opioids are drugs derived from the poppy plant. The clinical use of opioids to treat severe pain is widely accepted throughout the world. Despite their widespread use, opioid drugs have debilitating effects that limit their usefulness at all doses.

Chronic use may lead to tolerance, dependence, addiction or medical abuse. As a result, some patients prefer to suffer through pain rather than to endure the adverse effects of opioid drugs. Effective pain management is a growing and unmet need in the United States. For example, according to the National Institutes of Health, over 40 million Americans are unable to find relief from their pain.

About Pain Therapeutics, Inc.

Pain Therapeutics, Inc. is an emerging leader in the area of pain management. The Company is developing novel painkillers that address the deficiencies of oxycodone, morphine and other opioid painkillers that are widely used in clinical medicine. The Company is currently in Phase II clinical trials with multiple proprietary painkillers. Pain Therapeutics has headquarters in South San Francisco, California and is traded on NASDAQ under the symbol PTIE.

For additional information, please visit the Company's web site at

Zero tolerance?
Receptor regulation
Glycine anatagonists
Morphine and serotonin
Is morphine a smart drug?
Opioids, mood and cognition
Is morphine an antidepressant?
Depression, opioids and the HPA
Tolerance, sensitization and dependence
Anxiety, opioids, cholecystokinin and tolerance

Go To Good Drug Guide
BLTC Research
Designer Drugs
Utopian Pharmacology
The Hedonistic Imperative