FDA Approves Endometriosis Pain Management Treatment

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.

Both Orilissa treatment groups showed statistically significant greater mean decreases from baseline compared to placebo in daily menstrual pain and nonmenstrual pelvic pain at month six. Women in the phase 3 studies also provided a daily self-assessment of their endometriosis pain using a numeric rating scale (NRS), and women taking Orilissa 150 mg once daily and 200 mg twice daily reported a statistically (P <0.001) significant reduction from baseline in NRS scores compared to placebo at month three. Clinical trial data also demonstrated women taking the drug 200 mg twice daily showed statistically significant greater reduction in pain with sex from baseline to month three compared to placebo.

The recommended duration of use for Orilissa is up to 24 months for the 150 mg once daily dose and up to 6 months for the 200 mg twice daily dose, as it causes a dose-dependent decrease in BMD, which is greater with increasing duration of use, and may not be completely reversible after stopping treatment. For women with moderate hepatic impairment, the recommended dosage is 150 mg once daily for up to 6 months. Orilissa is recommended to be taken orally at approximately the same time each day, with or without food.

"Together with AbbVie, we are proud to offer a treatment option for the many women suffering from pain associated with endometriosis," said Kevin Gorman, PhD, chief executive officer of Neurocrine Biosciences, in a press release. "Neurocrine discovered ORILISSA nearly 20 years ago, and through our partnership with AbbVie, the approval of Orilissa reflects our joint commitment to develop therapies for difficult to manage conditions in underserved patient populations."

Reference

AbbVie Receives US FDA Approval of ORILISSA™ (elagolix) for the Management of Moderate to Severe Pain Associated with Endometriosis [news release]. North Chicago, IL; July 24, 2018: AbbVie. https://goo.gl/qGGpXF. Accessed July 24, 2018.