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 an early indication of FDA approval for Zipsor, a drug it developed to treat acute pain. It received an "approvable letter," which means the FDA is prepared to approve the application, but still needs some conditions satisfied. "Importantly, no additional clinical trials have been requested," Flexter says.
Started up 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
Enjoy this story?
Sign up for free solutions-based reporting in your inbox each week.