The scope of application of Esmia (ulipristal 5 mg) by the Hungarian Gedeon Richter is enlarged.
Until recently the drug was only used for preoperation therapy of moderate and severe symptoms of uterine leiomyoma in women of reproductive age.
However, results of long-term phase III clinical studies — PEARL III and its extension and PEARL IV,involving 132 patients and 451 patients, respectively, confirmed its efficacy and safety profile as a long-term treatment of moderate and severe symptoms of uterine leiomyoma. The new drug helped reduce the bleeding, size of lesion and pain.
Extension of indications including the option of long-term treatment of moderate and severe uterine leiomyoma symptoms will allow millions of women preserve their reproductive function and significantly improve the quality of life.
Exmia (ulipristal 5 mg) is approved by the Russian Ministry of Health for single or long term use for treatment of moderate and severe symptoms of uterine leiomyoma.