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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