FDA approves elagolix (Orilissa), the first and only oral treatment for endometriosis pain

The U.S. Food and Drug Administration (FDA) today approved ORILISSA™ (elagolix), the first and only oral gonadotropin-releasing hormone (GnRH) antagonist especially useful in the management of women with moderate to severe endometriosis pain— announced AbbVie and Neurocrine Biosciences.

Orilissa represents the first FDA approved oral treatment for endometriosis in over a decade and is expected to be available in U.S. retail pharmacies in early August 2018.

The drug is available in two oral dosages-150 mg once daily and 200 mg twice daily, taken with or without food roughly at the same time every day.

The FDA approval is supported by the results of 2 of the largest, randomized, double-blind, placebo-controlled phase 3 trials conducted to date, which evaluated nearly 1,700 women with moderate to severe endometriosis pain. Women either received 150 mg, 200 mg (952 women) or a placebo (734 women) and were evaluated at the end of 3 months.

Of the women in the treatment arm, 475 received a 150-mg daily dose, while and 477 received a 200-mg twice-daily dose.

Clinical trial results demonstrate that Orilissa significantly reduced all the 3 types of pain commonly associated with endometriosis— daily menstrual pelvic pain, non-menstrual pelvic pain, and pain with sex (p <0.001). Furthermore, women on 200 mg dose showed a significant reduction in dyspareunia as compared to placebo.

The most significant side effect observed with elagolix is dose-dependent decreases in bone mineral density; limiting the treatment to either 150 mg daily for up to 24 months or 200 mg twice daily for up to 6 months.

Bone mineral density loss is not entirely reversible on stopping the treatment. Other adverse effects are reported in 5% of patients and include hot flashes/night sweats, headache, and nausea, difficulty sleeping, an absence of periods, anxiety, joint pain, depression and mood changes.

"ORILISSA represents a significant advancement for women with endometriosis and physicians who need more options for the medical management of this disease," said Michael Severino, M.D., Executive Vice President, Research and Development and Chief Scientific Officer, AbbVie. "The approval of ORILISSA demonstrates AbbVie's continued commitment to address serious diseases and unmet needs."

"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."

AbbVie is going to role in an application for the approval of elagolix in Uterine Fibroids too; the drug has already shown promising results in initial trials conducted by the drug manufacturer.

AbbVie press release

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