FDA Clears Elagolix (Orilissa) for Endometriosis Pain

FDA Clears Elagolix (Orilissa) for Endometriosis Pain

The US Food and Drug Administration (FDA) has approved elagolix (Orilissa, AbbVie), the first oral gonadotropin-releasing hormone antagonist specifically developed for the treatment of moderate to severe pain associated with endometriosis, the company has announced.

The FDA approved elagolix under priority review. It is expected to be available in the United States next month.

Elagolix represents a “significant advancement for women with endometriosis and physicians who need more options for the medical management of this disease,” Michael Severino, MD, chief scientific officer at AbbVie, said in a news release.

Data from two studies involving nearly 1700 women with moderate to severe endometriosis pain supported FDA approval.

Elagolix, at a dose of 150 mg once daily or 200 mg twice daily, significantly reduced the three most common types of endometriosis pain: daily menstrual pelvic pain, nonmenstrual pelvic pain, and pain with sex, the company said.

The recommended duration of use of elagolix 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 bone mineral density (BMD), the company said.

Loss of BMD is greater with increasing duration of use and may not be completely reversible after stopping treatment, the company noted. For women with moderate hepatic impairment, the recommended dosage is 150 mg once daily for up to 6 months. The drug should be taken orally at roughly the same time each day, with or without food.

“Endometriosis is often characterized by chronic pelvic pain that can impact women’s daily activities,” Hugh Taylor, MD, study investigator from Yale University School of Medicine in New Haven, Connecticut, said in the release. “Women with endometriosis may undergo multiple medical treatments and surgical procedures seeking pain relief, and this approval gives physicians another option for treatment based on a woman’s specific type and severity of endometriosis pain.”

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