FDA Approves Elagolix (Orilissa) for Endometriosis Pain

On July 24th, 2018 the US Food and Drug Administration (FDA) approved Elagolix for the treatment of moderate to severe pain associated with endometriosis.

Dr. Robin Kroll, director of Seattle Clinical Research Center has conducted over a dozen clinical trials with the newly approved endometriosis treatment, Orilissa. The drug, Elagolix — now marketed as Orilissa — is made by AbbVie in partnership with Neurocrine Biosciences and is taken as a daily pill. Dr. Kroll, who has been involved in endometriosis trials as a principal investigator for over 20 years, commented, “Elagolix provides the first new treatment option for endometriosis in many years. We are very proud to have participated in the development program for this important new medication and expect that it will be a great benefit to women suffering from this devastating disease.”

Endometriosis, a condition in which tissue from the uterus grows outside the uterus, can lead to cysts, heavy bleeding, and scarring. It is estimated to affect one in ten women of reproductive age. It is often characterized by chronic pelvic pain that can prevent women from participating in normal daily activities. For some women with endometriosis, their monthly period pain can be as agonizing as labor pains or appendicitis and can result in several trips to the emergency room, yet that pain is often misconstrued as regular period cramps. Since it often mimics other conditions, it can take over a decade for a patient to receive a proper diagnosis.

The approval is supported by data from two replicate studies in the largest endometriosis Phase 3 study program conducted to date, which evaluated nearly 1,700 women with moderate to severe endometriosis pain.