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Patient Enrollment Complete for Phase 3 Trial of Drug To Treat Irritable Bowel Syndrome
This randomized, double-blind, multi-center study enrolled over 600 women diagnosed with IBS by a gastroenterologist according to the Rome II Criteria. This U.S. study is designed to compare the safety and efficacy of PTI-901 against placebo during a three-month treatment period. Women with constipation, diarrhea or alternating symptoms of IBS were enrolled in this study. The Company expects to announce top-line results of this study by year-end.
"The medical community uses the term 'irritable bowel syndrome' to describe a group of chronic, painful symptoms," said Nadav Friedmann, Ph.D., MD, chief operating and medical officer at Pain Therapeutics. "These symptoms often include abdominal pain, bloating, distension of the abdomen, constipation or diarrhea. This chronic condition is believed to cause serious discomfort for over 25 million Americans."
Pain Therapeutics is also conducting a Phase III study in 600 men with IBS. This study is similarly designed to the Phase III study with PTI-901 in women. The men's study continues to enroll patients at a slower rate than the women's study. We believe the difference in enrollment rates occurs because IBS affects more women than men.
PTI-901 (a single, daily, 0.5 mg oral dose of naltrexone HCl) is the first in a new class of drugs designed to restore the balance of opioid activity in the gut. It is believed that an imbalance of opioid activity in the gut contributes to the symptoms that comprise IBS. Such an imbalance may be triggered by emotional stress, metabolic disorders or intrinsic release of opioids from neurons in the gut. By restoring this balance, PTI-901 may relieve abdominal pain and other symptoms frequently observed in patients with IBS. Pain Therapeutics holds exclusive, worldwide commercial rights to a family of issued patents and patent applications directed to the long-term treatment of IBS patients with proprietary opioid antagonists, such as PTI-901.
In a previously reported 50 patient pilot study with PTI-901, patients with IBS reported a 76% response rate to PTI-901. This response rate was observed in men and women and occurred without drug-related safety issues.
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.
Source: Pain Therapeutics, Inc.