FDA Approves Orilissa for Treatment of Endometriosis Pain

Officials with the FDA have approved elagolix (Orilissa, AbbVie), a product specifically developed for women with moderate to severe endometriosis pain. According to AbbVie, Orilissa is the first and only oral gonadotropin-releasing hormone (GnRH) antagonist developed for this intended use.

Developed by AbbVie in cooperation with Neurocrine Biosciences, the product is expected to be made available in retail pharmacies by early August. It is not recommended for patients who are pregnant or trying to become pregnant, those who have osteoporosis or severe liver disease, and individuals who take medicines known as strong OATP1B1 inhibitors. In addition, elagolix may cause a decrease in bone mineral density (BMD), according to AbbVie.

The drug’s approval is supported by data from 2 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. Clinical trial data demonstrated Orilissa significantly reduced the 3 most common types of endometriosis pain: daily menstrual pelvic pain, nonmenstrual pelvic pain, and pain with sex. A higher proportion of women treated with Orilissa 150 mg once daily and 200 mg twice daily were responders for daily menstrual pain and nonmenstrual pelvic pain compared to placebo in a dose-dependent manner at month three. Women were defined as responders if they experienced a reduction in daily menstrual pain and nonmenstrual pelvic pain with no increase in analgesic use (nonsteroidal anti-inflammatory drug or opioid) for endometriosis-associated pain.

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