Friday, August 10, 2007

Wyeth halts testing on Pristiq

Wyeth has experienced another setback with the experimental drug Pristiq, revealing that it has halted clinical trials for treating a chronic condition that causes fatigue and pain in muscles and joints.

Wyeth said it was stopping work on testing the drug's effectiveness in treating fibromyalgia, which was one of several intended uses for Pristiq. However, the drug also has run into delays at the Food and Drug Administration on applications to treat menopausal symptoms and depression.

The study for fibromyalgia was halted during the enrollment of patients in the second of three clinical-trial phases required before a drug is submitted to regulators.

The company stopped enrollment "after reviewing a planned interim data analysis" and determining that Pristiq wouldn't outperform a placebo in pain relief, Wyeth said in a document filed with the Securities and Exchange Commission after markets had closed Tuesday. "This decision was not made because of safety reasons," the company said.

Fibromyalgia represents a solid but elusive market opportunity. The FDA says fibromyalgia affects about 3 million to 6 million Americans annually, primarily women. The cause isn't clear, and there is no diagnostic test.

Until recently, there hadn't been an FDA-approved drug. Instead, patients shuttled from pain medications to muscle relaxants and from antidepressants to sleep medications as they tried to find relief.


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