FDA approves first endometriosis pain management drug in a decade
pharmafile | July 25, 2018 | News story | Research and Development, Sales and Marketing |Â Â AbbVie, FDA, Neurocrine Biosciences, endometriosis, pharmaÂ
The FDA has confirmed its approval of AbbVie and Neurocrine Biosciences’ Orilissa (elagolix), a nonpeptide small molecule gonadotropin-releasing hormone (GnRH) receptor antagonist, for the management of moderate to severe pain associated with endometriosis.
According to the manufacturers, the drug is the first and only of its kind specifically developed for women suffering from the condition, and it is also the first FDA-approved oral treatment for the condition in a decade. Endometriosis is one of the most common gynaecologic conditions in the US, affecting one in ten women of reproductive age.
The decision, made under priority review, was based on two Phase 3 studies conducted as part of the largest endometriosis trial conducted to date, including almost 1,700 female participants. The data showed that Orilissa significantly reduced the three most common types of pain associated with the condition: daily menstrual pelvic pain, non-menstrual pelvic pain and pain with sex. After six months of treatment, both patients treated with 150mg daily or 200mg daily showed statistically significant greater mean decreases from baseline compared to placebo in daily menstrual pain and non-menstrual pelvic pain.
“Endometriosis is often characterised by chronic pelvic pain that can impact women’s daily activities,” said Dr Hugh S Taylor, study investigator and Chair of the Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine. “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.”
Dr Kevin Gorman, Chief Executive Officer of Neurocrine Biosciences, also remarked: “Together with AbbVie, we are proud to offer a treatment option for the many women suffering from pain associated with endometriosis. Neurocrine discovered Orilissa nearly twenty 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.”
Matt Fellows
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