To: tuck who wrote (594 ) 1/18/2002 2:48:52 PM From: tuck Respond to of 1005 >>SOUTH SAN FRANCISCO, Calif., Jan. 18 /PRNewswire-FirstCall/ -- Pain Therapeutics, Inc. (Nasdaq: PTIE - news), a medical research company, today announced that the Medicines Control Agency (the British equivalent of the U.S. Food and Drug Administration) has granted the Company permission to initiate a clinical study in the United Kingdom with its novel painkiller PTI-801. The Company believes PTI-801 is a safer form of immediate release oxycodone, a widely prescribed narcotic painkiller. U.S. sales of oxycodone exceeded $1 billion last year. ``Our vision for PTI-801 is simply to develop a safer version of oxycodone,'' said Remi Barbier, president and chief executive officer of Pain Therapeutics. ``PTI-801 is a novel form of oxycodone that we believe minimizes the abuse and drug dependence that is often associated with oxycodone and other narcotic painkillers. The goal of developing PTI-801 is to ensure the safety of patients who have a legitimate medical need to treat severe chronic pain with a narcotic painkiller, and to protect the public from the consequences of abuse.'' Now that regulatory filings in England have been accepted, the Company plans to move PTI-801 into comprehensive clinical trials. Both the Medicines Control Agency and the local Institutional Review Board have approved the Company's protocol to conduct a clinical study in the U.K. The Company plans to initiate a Phase II multi-dose safety and pharmacokinetic clinical study in England with PTI-801 in the first quarter of 2002, to be followed by large efficacy studies. The Company expects its clinical results to support regulatory filings for approval in both the U.S. and in Europe. About Opioid Painkillers Opioid (``narcotic'') painkillers are drugs derived from opium and the poppy plant. The clinical use of opioid drugs to treat severe pain is widely accepted throughout the world. In the United States, opioid drugs exceed $3 billion in annual sales and account for over five percent of all prescription drug sales. Despite widespread use, opioid painkillers have debilitating effects that limit their usefulness at all doses. Chronic use may lead to tolerance, dependence, abuse, or, more rarely, addiction. As a result, some patients prefer to suffer through pain rather than endure the ill effects of opioid drugs. The under-treatment of pain is a serious and growing problem in the U.S. For example, according to the National Institutes of Health, over 40 million Americans are unable to find relief from their pain.<< snip Cheers, Tuck