In Q4 2017, the
"Based on our review of the data, we remain confident in our New Drug Application for elagolix in the treatment of endometriosis-associated pain," said
The NDA for elagolix is supported by data from the largest prospective randomized clinical trials conducted to date for endometriosis. The safety and efficacy of elagolix were evaluated in nearly 1,700 women with moderate-to-severe endometriosis-associated pain. Clinical trial data demonstrated elagolix was well-tolerated and significantly reduced the three types of endometriosis-associated pain – daily menstrual pelvic pain, non-menstrual pelvic pain and painful intercourse.
About Elagolix
Elagolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, is an orally administered, short-acting molecule that blocks endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland. Administration results in readily reversible, dose-dependent inhibition of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion, leading to reduced ovarian production of the ovarian sex hormones, estradiol and progesterone, while on therapy. Elagolix is currently being investigated in diseases that are mediated by ovarian sex hormones, such as uterine fibroids and endometriosis. To date, elagolix has been studied in over 40 clinical trials totaling more than 3,000 subjects.
About Endometriosis
Endometriosis occurs when tissue similar to that normally found in the uterus begins to grow outside of the uterus, leading to long-term pelvic pain (during or between periods), pain with intercourse and other painful symptoms.1 These growths are called lesions and can occur on the ovaries, the fallopian tubes, or other areas near the uterus, such as the bowel or bladder.1,2 Estrogen fuels the growth of lesions.2 There is no cure for endometriosis,3 and the associated pain is currently managed with oral contraceptives, progestins, danazol, nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and GnRH agonists, many of which are not specifically indicated for the treatment of endometriosis.2 In more extensive cases, surgical interventions (e.g., laparotomy or laparoscopy) are often pursued, and may not be curative for all individuals.4
About
About Neurocrine Biosciences, Inc.
Neurocrine Biosciences is a San Diego based biotechnology company focused on neurologic, psychiatric and endocrine related disorders. The Company markets INGREZZA® (valbenazine) capsules in the United States for the treatment of adults with tardive dyskinesia. INGREZZA is a novel, selective vesicular monoamine transporter 2 (VMAT2) inhibitor, and is the first FDA approved product indicated for the treatment of adults with tardive dyskinesia. The Company's three late-stage clinical programs are: elagolix, a gonadotropin-releasing hormone antagonist for women's health that is partnered with AbbVie Inc.; opicapone, a novel, once-daily, peripherally-acting, highly-selective catechol-o-methyltransferase inhibitor under investigation as adjunct therapy to levodopa in Parkinson's patients; and INGREZZA, a novel, once-daily, selective VMAT2 inhibitor under investigation for the treatment of Tourette syndrome.
AbbVie Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements.
1 The American College of Obstetricians and Gynecologists. ACOG Education Pamphlet AP013: Endometriosis. Washington, DC: September 2008. ISSN 1074-8601. | ||
2 Giudice LC. Clinical practice: Endometriosis. New England Journal of Medicine. 2010; 362:2389–2398. | ||
3 Greene, AD, Lang, SA, Kendziorski, JA, Sroga-Rios, JM, Herzog, TJ, Burns, KA. Endometriosis: where are we and where are we going? Reproduction. 2016; 152 (3):R63-78. | ||
4 Mayo Clinic. Diseases & Conditions: Endometriosis Fact Sheet. http://www.mayoclinic.org/diseases-conditions/endometriosis/diagnosis-treatment/treatment/txc-20236449. Accessed June 1, 2017. |
SOURCE
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Media
Jackie Finley
jaquelin.finley@abbvie.com
(847) 937-3998 or
Investors
Liz Shea
liz.shea@abbvie.com
(847) 935-2211