FDA approves Orilissa to treat endometriosis pain

The FDA on Tuesday approved the first oral gonadotropin-releasing hormone antagonist indicated for women with moderate to severe endometriosis pain, AbbVie and Neurocrine Biosciences announced in a press release.

The approval of elagolix (Orilissa) represents the first oral therapy for the management of moderate to severe pain associated with endometriosis in more than a decade, according to the release. Elagolix is available in two oral dosages of 150 mg and 200 mg twice daily, taken with or without food.

“Orilissa represents a significant advancement for women with endometriosis and physicians who need more options for the medical management of this disease,” Michael Severino, MD, executive vice president of research and development and chief scientific officer at AbbVie, said in the release. “The approval of Orilissa demonstrates AbbVie’s continued commitment to address serious diseases and unmet needs.”

As Healio.com has previously reported, endometriosis affects 6% to 10% of women of reproductive age, according to the American College of Obstetricians and Gynecologists. By some estimates, endometriosis has direct costs of $12,118 per patient, per year in the United States. Endometriosis-associated pain is often managed with medicines such as oral contraceptives, NSAIDs, opioids and hormonal therapies. In more extensive cases, surgical interventions (eg, laparotomy, laparoscopy or hysterectomy) are often pursued and may not be curative for all individuals.

“Together with AbbVie, we are proud to offer a treatment option for the many women suffering from pain associated with endometriosis,” Kevin Gorman, PhD, CEO of Neurocrine Biosciences, said in the 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.”

In two phase 3 extension studies reported by Healio Family Medicine, elagolix demonstrated a long-term sustained reduction in average monthly menstrual pelvic pain, nonmenstrual pelvic pain and painful intercourse in women with endometriosis, without compromising safety or tolerability.

Researchers conducted two extension studies (Elaris EM-III and Elaris EM-IV) to determine whether two doses of elagolix — 150 mg once daily and 200 mg twice daily — are safe and effective long-term options for the management of endometriosis with associated pain. The studies assessed an additional 6 months of treatment each for a total of 12 months in women aged 18 to 49 years who were surgically diagnosed with endometriosis and had moderate to severe pain related to endometriosis at baseline.

The researchers evaluated efficacy by calculating the reduction of participants’ average monthly menstrual pain and nonmenstrual pelvic pain scores, which were measured using the Daily Assessment of Endometriosis Pain scale. They assessed safety by evaluating adverse events and changes in bone mineral density.

Researchers found that across both extension studies and for both elagolix doses, menstrual pain and nonmenstrual pelvic pain were reduced after 6 months of treatment and maintained during an additional 6 months. Participants receiving the 200-mg dose of elagolix reported more painful intercourse after 12 months than those receiving the 150-mg dose.

Overall, 4% to 8% of participants experienced new incidences of hot flush. At month 12, there was a dose-dependent average decline from baseline in BMD (0.6% and 1.1% with 150 mg in EM-III and EM-IV, respectively; and 3.6% and 3.9% with 200 mg in EM-III and EM-IV, respectively).

The recommended duration of use for 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 BMD, according to the release. BMD loss 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.

Elagolix is expected to be available in U.S. retail pharmacies in early August, according to the companies. – by Regina Schaffer