AbbVie Notches FDA Approval for Endometriosis Pain Treatment

- July 24th, 2018

The company says the drug has a projected availability date of August 2018 in US retail pharmacies. It is the first FDA-approved oral treatment for alleviating pain associated with endometriosis.

AbbVie (NYSE:ABBV) received promising news from the US Food and Drug Administration (FDA) on Tuesday (July 24) with the organization approving AbbVie’s–in connection with Neurocrine Biosciences (NASDAQ:NBIX)–ORILISSA drug that treats moderate to severe pain caused by endometriosis.

The company in its press release stated the FDA approved ORILISSA under priority review, and is the first FDA-approved oral treatment for alleviating endometriosis in over 10 years.

ORILISSA has a projected availability date in US retail pharmacies by as early as August 2018, AbbVie said.

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

The drug was tested in two replicate studies in a Phased 3 study program that evaluated over 1,700 women with moderate to severe endometriosis.

Clinical data trial showed that ORILISSA had a heavy hand in reducing the most common types of pain associated with endometriosis, including: daily menstrual pelvic pain, non-menstrual pelvic pain, and pain associated with intercourse.

Women treated with ORILISSA 150 mg once a day and 200 mg twice a day were responders for both daily menstrual pain and non-menstrual pelvic pain compared to a placebo in a “dose-dependent manner” by the third month.  If women experienced reduced pain in those two categories with no increase in analgesic use for pain associated with endometriosis, they were considered responders to the drug.

The release said both treatment groups experienced a decrease from baseline compared to placebo in daily menstrual pain and non-menstrual pelvic pain by the sixth month.

Endometriosis impacts women mostly between the ages of 25-35 and affects roughly 1-in-10 women worldwide, and can last anywhere between six and 10 years.

The disease happens when tissue similar to it typically found in the uterus starts growing outside of the uterus, resulting in a wide range of symptoms, most notably the ones listed above. Growths caused by endometriosis can be found on the ovaries, the fallopian tubes and/or other areas around the uterus.

“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,” Kevin Gorman, Ph.D and CEO of Neurocrine Biosciences said in the release.

Shares of AbbVie were up 2.39 percent on Tuesday to close the trading session at US$91.54. The company currently has a moderate buy ranking on TipRanks based off seven analyst ratings with an average price target of US$107.83, a high estimate of US$135, and low estimate of US$78.

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Securities Disclosure: I, Jocelyn Aspa, hold no direct investment interest in any company mentioned in this article.

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