The U.S. Food and Drug Administration recently approved Orilissa (elagolix), the first and only oral gonadotropin-releasing hormone (GnRH) antagonist specifically developed for women with moderate to severe endometriosis pain. Orilissa represents the first FDA-approved oral treatment for the management of moderate to severe pain associated with endometriosis in over a decade, according to AbbVie, the pharmaceutical company behind the drug.
“Orilissa represents a significant advancement for women with endometriosis and physicians who need more options for the medical management of this disease,” said Michael Severino, M.D., Executive Vice President, Research and Development and Chief Scientific Officer, for AbbVie.
Endometriosis is one of the most common gynecologic disorders in the U.S. It affects an estimated one in 10 women of reproductive age and can be associated with pain symptoms that can be debilitating. Women can suffer for up to six to 10 years and visit multiple physicians before receiving a proper diagnosis.
The approval is supported by data from two studies, which evaluated nearly 1,700 women with moderate to severe endometriosis pain. Clinical trial data demonstrated Orilissa significantly reduced the three most common types of endometriosis pain: daily menstrual pelvic pain, non-menstrual pelvic pain and pain with sex.