FDA-Approved Orilissa: Treatment or Manageable Medicine?

Last Tuesday, 24 July, the U.S. Food and Drug Administration approved a new treatment for endometriosis called Orillissa.

The treatment, which is administered as a daily pill, uses a nonpeptide small molecule gonadotropin-releasing hormone antagonist (GnRH) that decreases blood concentrations of ovarian sex hormones, estradiol and progesterone. GnRH is also typically used in the treatments of prostate cancer, uterine fibroids and infertility in assisted reproduction.

The approval is supported by data from two replicate studies which evaluated more than 1,700 women with moderate to severe endometriosis pain. The clinical trial data showed 150 to 200mg of the pill reduced the three most common types of endometriosis pain: daily menstrual pelvic pain, non-menstrual pelvic pain and pain with sex.

Another Phase 3 trial evaluated the pill’s potential to treat uterine fibroids. Its researchers reported that, when combined with low-dose hormone therapy, Orilissa reduced heavy menstrual bleeding.

However, the pill can potentially cause a dose-dependent decrease in bone mineral density (BMD) and also puts users at risk of early miscarriage, abnormal liver tests and suicidal thoughts.

AbbVie, a publicly traded U.S. biopharmaceutical company, considers the pill the "first FDA-approved oral treatment for the management of moderate to severe pain associated with endometriosis in over a decade."

It will be available in U.S. pharmacies in early August 2018, and will cost cost $844,87 a month, or $10.138,44 a year.

Speaking with Endometriosis News, Tamer Seckin, MD, founder and medical director of the Endometriosis Foundation of America, called the FDA’s approval of Orilissa "truly incredible news". 

He also warns that patients should be "cautiously optimistic" of the pill's benefits, and refers to the pill as a "manageable medicine" rather than a treatment.

"We know that when the disease has lasted for many years, at that advanced stage if the disease is not removed, these medications do not have very good outcomes," he said.

He emphasized that medications like Orilissa "don’t really eradicate the disease or make the lesions disappear." However, he remains optimistic that the pill will bring relief to some groups of patients.

When taking to Facebook, many users with endometriosis consider Orilissa another form of Lupron: a doctor-administered injection that relieves endometriosis pain and reduces lesions.

These users do not consider Lupron as a cure for endometriosis, but rather a bandaid that can potentially cause premature menopause. They also remain skeptical to Orilissa considering its similar relief methods and its price.

Aside from a cure, most girls and women with endometriosis want to be heard, and would rather healthcare professionals focus on developing effective diagnostic measures, proper pain relief and raising awareness about endometriosis among the healthcare sector.

EndoMetrix is actively looking for ways to do just that as we continue to develop an app that provides a care plan specifically catered to each individual user. However, in order to properly meet your needs, we need your input! Follow the link below to become a test user with us today, so we can ensure that we make an app that helps all girls and women properly treat their own version of endometriosis, fibroids, PCOS or other gynaecological disorders.