Watson starts phase-3 trial of Esmya

Drug maker investigates drug in women with uterine fibroids

PARSIPPANY, N.J. — Drug maker Watson Pharmaceuticals has started a late-stage trial of a drug made to treat benign tumors of the uterus, the company said Monday.

Watson announced the initiation of a phase-3 trial of Esmya (ulitristal acetate) in women who have anemia due to uterine leimyomas, also known as uterine fibroids, which causes benign solid tumors that can lead to excessive menstrual bleeding, anemia and pain and may require surgery. Watson is developing the drug under a licensing agreement with Gedeon Richter.

"Initiation of the U.S. pivotal trial is underway on schedule, and we are hopeful that this phase 3 study will demonstrate improvement on pre-surgical hemoglobin concentrations, an expoint indicating that heavy bleeding and anemia have been alleviated," Watson EVP global brands Fred Wilkinson said. "Esmya, if approved, may be an important medicine for women whose fibroid-symptom severity often leads to excessive bleeding and related pain."


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