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Pain Therapeutics, Inc. For More Information Contact: Christi Waarich Manager of Investor Relations Pain Therapeutics, Inc. cwaarich###paintrials.com 650-825-3324FOR IMMEDIATE RELEASE PAIN THERAPEUTICS� NEW DRUG MARKEDLY IMPROVED PATIENTS WITH IRRITABLE BOWEL SYNDROME (IBS) -- Company�s First Clinical Results in IBS With a New Class of Drugs -- SOUTH SAN FRANCISCO, Calif. � May 29, 2003 � Pain Therapeutics, Inc. (Nasdaq: PTIE), announced today that PTI-901, the first of a new class of drugs developed to treat irritable bowel syndrome, significantly improved all the common symptoms associated with IBS. In a 50 patient pilot clinical study, patients of both gender reported a response rate of 76.2% at the conclusion of the four-week study (N=42). The magnitude of the benefit far exceeded what this pilot study was designed to demonstrate. The study also met the secondary endpoints of improving daily abdominal pain, bowel habits and stool consistency. These improvements were observed in patients whose baseline symptoms were either diarrhea or constipation, or both. No drug-related adverse events were observed. �This study met its primary endpoint,� said Remi Barbier, president and chief executive officer of Pain Therapeutics, Inc. �These results reinforce our faith that PTI-901 has the potential to become the standard drug therapy for patients who suffer from IBS. We believe a safe and effective drug to treat both men and women who suffer from IBS represents a $1 billion market opportunity in the United States alone.�The male and female response rate was 76.5% (N=17) and 75.0% (N=25) respectively. In addition, patients on PTI-901 reported a 193% increase in number of pain-free days at Week 4 compared to baseline (N=37). Significant clinical improvements in bowel urgency, stool consistency and number of stools per day were also reported at Week 4 in both genders. PTI-901 was well tolerated by all patients during the entire treatment period. �In this study, PTI-901 had a clean safety profile and provided rapid and sustained relief of abdominal pain for patients with IBS,� added Nadav Friedmann, Ph.D., MD, chief medical and operating officer of Pain Therapeutics, Inc. �Significantly, these clinical benefits were observed in IBS patients regardless of gender. These data encourage us to evaluate PTI-901 in a Phase III trial designed to support product approval.� Pain Therapeutics believes this study presents clinical validation of the novel hypothesis that IBS patients suffer from an abnormal imbalance of opioid activity in the gut. Such an imbalance may be triggered by emotional stress, metabolic disorders or intrinsic release of opioids from gut neurons. The Company and its scientific collaborators believe that chronic administration of very low doses of an opioid antagonist, such as the investigational new drug PTI-901, restores the proper level of opioid activity in the gut. This relieves abdominal pain and other symptoms frequently observed in patients with IBS. The Company holds exclusive, worldwide commercial rights in a family of issued patents and patent applications, including two issued U.S. patents in this area. Pain Therapeutics and its principal investigator intend to submit an abstract of this trial to the Annual Scientific Meeting of the American College of Gastroenterology, which will be held in Baltimore in October 2003. The Company plans to follow-up this pilot clinical study with a 600 patient Phase III pivotal trial in the United States. The Company�s registration strategy will ultimately depend on PTI-901�s level of activity in pivotal Phase III studies and on discussions with regulatory agencies. Study Detail The purpose of this open-label study was to evaluate the clinical effects of PTI-901 (low-dose naltrexone HCI) in patients with IBS. A total of 50 patients were enrolled. All patients were diagnosed with IBS by a gastroenterologist according to Rome II Criteria. Treatment consisted of 0.5 mg dose of PTI-901 daily over a four-week period. Patients were evaluated for abdominal pain, bowel habits and stool consistency at baseline and at the end of weeks 1 through 4. The primary efficacy endpoint was the patients� observations of Global Assessment of Adequacy of Treatment. Secondary efficacy endpoints included abdominal pain and bowel habits. The study was conducted at the Sourasky Medical Center in Israel under an Investigational New Drug (IND) Application filed with the U.S. Food and Drug Administration (FDA). Existing IBS Drugs The FDA has approved two drugs to treat women with certain types of IBS (no drug therapy is currently FDA approved for men with IBS): GlaxoSmithKline�s Lotronex� and Novartis� Zelnorm�. According to Physicians� Desk Reference, the response rate and placebo rate for women on Lotronex� are approximately 50% and 35% respectively at Week 4. The response rate and placebo rate for women on Zelnorm� are approximately 58% and 50% respectively at Week 4.About Irritable Bowel Syndrome (IBS) IBS is a chronic, painful abdominal disorder that leads to major changes in bowel habits. IBS causes some patients to have constipation, diarrhea or in some cases both. The cause of IBS is not known, and as yet there is no cure. People with chronic IBS may be unable to attend social events, hold a job, or travel away from home. Over 10 percent of the U.S. population suffers from IBS. For unknown reasons, IBS predominantly affects women. About Pain Therapeutics, Inc. We are a medical research company specializing in the discovery and development of novel proprietary painkillers. We believe one of our lead drug candidates, Oxytrex�, may offer more pain relief (with no increase in side-effects) or lower tolerance/dependence, withdrawal effects or addiction potential compared to conventional forms of oxycodone. The market for oxycodone exceeded $1.5 billion in the United States in 2002. Another drug candidate, PTI-901, is aimed at treating patients who suffer from abdominal pain associated with Irritable Bowel Syndrome. For more information, please visit our website at www.paintrials.com. Note Regarding Forward-Looking Statements: This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 and it is Pain Therapeutics� intent that such statements be protected by the safe harbor created thereby. Examples of such statements include, but are not limited to, any statements relating to the potential benefits of PTI-901 for the treatment of IBS, the size, scope, goals, or timing of the Company�s pivotal trial with PTI-901, the benefits that may be derived from the Company�s patents or technology, 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, including, but not limited to, risks and uncertainties relating to difficulties or delays in development, enrolling and conducting clinical trials such as the IBS study, 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 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 and the Company's ability to obtain additional financing if necessary. 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, including its Form 10-K for the year ended December 31, 2002 and its subsequent quarterly filings.
 

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I H8,send the other acrobat text too.Tell me how.Another one wait to be transfer.Thank
 

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I'm asking me again why the people on Naltrexone here have not been cured apparently.Bad supervision?Here the today news from Pain therapeutics: http://www.tvmvc.com/
 

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I found this stunning discovery from 2000 but very interesting.Methylnaltrexone Reverses Opioid-Induced ConstipationCHICAGO, IL -- January 18, 2000 -- Methylnaltrexone, a drug designed to reverse one of the most troubling problems caused by opium-based analgesics without interfering with pain relief, is rapidly effective at low doses with no apparent side effects report researchers from the University of Chicago Medical Center in the January 19, 2000, issue of the Journal of the American Medical Association (JAMA). More than 250,000 terminal cancer patients each year take opioids, such as morphine, for pain relief. About half of those patients experience severe constipation. The discomfort can be so great that many patients choose to forego the pain relief in order to avoid the constipation. In this double-blind, placebo-controlled study, methylnaltrexone promptly reversed opioid-induced constipation. In more than 90 percent of patients, relief came within one minute of the first infusion. "By preventing this debilitating but little-discussed problem, methylnaltrexone could substantially enhance the quality of the last months of life for terminal cancer patients and others who depend on opioid pain relievers," said the study's first author Chun-Su Yuan, M.D., Ph.D., assistant professor of anesthesia and critical care at the University of Chicago. "Our current challenge," notes his co-author Joseph Foss, M.D., assistant professor of anesthesia at the University of Chicago, "is to make this drug available to the patients who need it, so that they won't have to choose between inadequate pain relief and debilitating constipation." Methylnaltrexone has been intensively studied, primarily at the University of Chicago, but with only limited support from the pharmaceutical industry. "The costs of developing a new drug are substantial," explained Foss. "With a medication designed for short-term use by a fairly small group of users -- fewer than 150,000 people -- manufacturers may fear it would be difficult to recoup that investment, but this drug is near the end of its development cycle and could potentially be brought to market quickly." Methylnaltrexone was invented in 1979 by the late University of Chicago pharmacologist Leon Goldberg, who wanted to help a dying friend who suffered from morphine-induced constipation. Goldberg started with naltrexone, an established drug that completely blocks the effects of morphine. He altered the drug slightly by attaching a methyl group, which changed the charge of the molecule so that it could no longer cross the protective barrier that surrounds the brain. Consequently, it did not interfere with morphine's effect on pain, which is centered in the brain, but it did block morphine's effects on gut motility, which are mediated by receptors in the peripheral gastrointestinal tract. It worked like a charm for his dying friend, who shared the drug with several of his friends also suffering from cancer. Its initial success in this compassionate-use setting drew the notice of Goldberg's colleagues. After Goldberg's demise, they continued to develop the compound, testing it in animals, performing the initial human safety trials and a completing a series of pre-clinical studies in volunteers. In this JAMA study, rather than risk interrupting pain relief for patients with terminal cancer, the researchers focused on 22 volunteers who were enrolled in a methadone maintenance program for opioid addiction. All 22 suffered from opioid-induced constipation, which affects about 60 percent of long-term methadone users. The volunteers averaged 1.5 bowel movements a week. Eleven of the 22 subjects received low doses of intravenous methylnaltrexone and 11 received a placebo. Ten of the 11 who received the drug had an immediate laxation response following the first infusion and all 11 responded to a second infusion on day two. "By immediate response we mean you did not want to be between the subject and the bathroom," explains Foss. All 11 reported rapid onset of mild to moderate abdominal cramping, which they described as being "similar to a defecation sensation, without discomfort." The cramping disappeared after a bowel movement. None of the subjects reported symptoms of opioid withdrawal, indicating that the drug, as expected, did not cross the blood-brain barrier and would not interfere with pain relief. At the end of the study, all 11 who received methylnaltrexone reported that they were "satisfied" with their bowel-movement activity. Eight reported that they were "very satisfied." None of the patients who received placebo had a laxation response, cramping, or a change in bowel movement frequency. Seven reported that they were "disappointed." Because opioids slow down the entire digestive process, the researchers also measured oral-cecal transit time, how long it took for food to travel from the mouth to the cecum -- the chamber at the beginning of the large intestine. Under the influence of methadone, the 22 subjects had an average transit time of more than two hours, about twice the normal speed. This interval did not change for those in the placebo group, but for the 11 subjects who received methylnaltrexone, oral-cecal transit time fell from an average of 132.3 minutes without the drug down to 54.5 minutes after treatment. The next step, say the researchers, is to find a U.S. pharmaceutical company to support a phase-III clinical trial in patients with advanced cancer. One trial, using an oral preparation, is already underway in cancer patients receiving palliative care at St. Christopher's Hospice, outside London. Related Link: Journal of the American Medical Association.
 
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WOW! this is very interesting stuff. But I'm confused. Why would naltrexone help all sufferers of ibs? Wouldn't naltrexone cause more spasms,trapped gas and diarhhea in a lot of us? Wouldn't it only be useful if you had C type? It sounds like it acts like a stimulant - or am I wrong? And wouldn't Dan the Man's use of methadone cause constipation C-predominant ibs patients?
 

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Dan have no c.Some members have tried low Nal.but apparently with low results.Anyway,it sound good.
 

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Actually,i'm jealous about the health of Dan.No pain,no side effects,no ibs,no addiction,resident of California...
 

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quote:Why would naltrexone help all sufferers of ibs? Wouldn't naltrexone cause more spasms,trapped gas and diarhhea in a lot of us?
The effects of opiates are complicated. Different parts of the gut are affected in different ways and there are multiple effects over time. Opiates increase and decrease gut motility in sequence, but that is even simplified because the effects are different depending on whether you are talking about the small intestine or the colon. It is probably reasonable to say in general that opiates decrease peristalsis but at the same time increase tone and increase segmenting contractions. As some people might like to put it, they cause spasms.In addition, loperamide decreases secretion and enhances absorption and this is primary reason drugs like these are used to treat diarrhea.As for pain, theoretically, it should increase pain threshold (meaning to reduce pain) because that effect begins in peripherally (along gut-brain axis) and not centrally (in the brain).Naltrexone would generally have the opposite effects of opiates, but because of their complex effects, it is really hard to say how they will bear on one's symptoms.
 

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Naltrexone,Methadone(Dolophine) are opioids antagonist.The fear of opioids is called opiophobia.Few members here seems to have some symptoms.
 

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Dr. Flux said:
As for pain, theoretically, it should increase pain threshold (meaning to reduce pain) because that effect begins in peripherally (along gut-brain axis) and not centrally (in the brain).Naltrexone would generally have the opposite effects of opiates, but because of their complex effects, it is really hard to say how they will bear on one's symptoms.That's this kind of effects i looking for.But i'mstill questionning me about the range of "the opposite effects".
 
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