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ORILISSA Approved for Moderate to Severe Endometriosis Pain

Antagonist has been shown to reduce menstrual and non-menstrual pelvic pain

A PPM Brief

FDA has approved ORILISSA (elagolix, AbbVie),1 an oral gonadotropin-releasing hormone (GnRH) antagonist developed for women with moderate to severe pain associated with endometriosis. Supported by data from two Phase 3 studies, evaluations of nearly 1,700 women found that ORILISSA significantly reduced the three most common types of endometriosis pain: daily menstrual pelvic pain, non-menstrual pelvic pain, and pain with sex.

"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," said Hugh S. Taylor, MD, study investigator and chair of the Department of Obstetrics, Gynecology and Reproductive Sciences at Yale School of Medicine.

In the studies, a majority of women responders treated with ORILISSA at 150 mg once daily or 200 mg twice daily had daily menstrual pain and non-menstrual pelvic pain compared to placebo in a dose-dependent manner at month three. Both ORILISSA treatment groups showed statistically significant greater mean decreases from baseline compared to placebo in daily menstrual pain and non-menstrual pelvic pain at month six. Responders 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; women taking ORILISSA 200 mg twice daily also showed statistically significant greater reduction in pain with sex from baseline to month three when compared to placebo.

ORILISSA is expected to be available in US retail pharmacies in early August 2018. The recommended duration and dose for ORILISSA is up to 24 months for one daily dose of 150 mg or up to six months at 200 mg twice-daily dose.

Last updated on: July 27, 2018
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Advances in the Diagnosis and Treatment of Chronic Pelvic Pain
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