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news.Pain Therapeutics has completed patient enrollment for a phase III trial examining irritable bowel syndrome in women. The study will investigate the drug PTI-901 which is believed to utilize a new mechanism of action suitable to treat of chronic forms of the disorder.
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The multi-center study has enrolled over 600 women diagnosed with irritable bowel syndrome (IBS). This US investigation 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 have been enrolled. The company expects to announce results of this study by the end of the year.
“The medical community uses the term ‘irritable bowel syndrome’ to describe a group of chronic, painful symptoms,” explained Dr Nadav Friedmann, 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. Pain Therapeutics believes the difference in enrollment rates occurs because IBS affects fewer men than women.
The treatment, PTI-901 (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 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 the drug. This response rate was observed in men and women and occurred without drug-related safety issues.