Xanodyne Pharmaceuticals moves forward with two under-development drugs

Xanodyne Pharmaceuticals, Inc. is moving forward with the development of two new drugs, as both achieved significant milestones recently. The Newport-based company is targeting early 2009 to file a formal new drug application with the FDA for a product to treat menorrhagia, or heavy menstrual bleeding.  If ultimately approved, it would be the first pharmaceutical product in the U.S. specifically designed to treat the problem. Xanodyne just announced positive results in two Phase 3 clinical trials that tested how well the drug works and its safety. The trials are key steps toward making a formal filing with the FDA. "We look forward to continuing to work with the U.S. Food and Drug Administration to complete the registration process for what we hope may be an important new therapeutic approach to treating this disabling condition," says Gregory D. Flexter, Xanodyne's CEO.

Xandodyne has also received  FDA approval for Zipsor, a drug it developed to treat acute pain. Its unique formulation is designed for rapid and consistent release while minimizing systemic exposure. “Xanodyne is pleased with this action and will work closely with the FDA to provide a complete response.” said Gregory D. Flexter, President and Chief Executive Officer of Xanodyne.  Started in 2001, Xanodyne is a specialty pharmaceutical firm that develops and sells drugs focused on women’s health care and pain management.

Writer: David Holthaus
Source: Thomas Jennings, Xanodyne

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