AbbVie Inc. (ABBV, Financial) released encouraging data Wednesday for women with chronic pelvic pain, due to endometriosis, who are waiting for a treatment that can improve the quality of their lives.
The data demonstrate that elagolix in premenopausal women who suffer from endometriosis significantly reduces the menstrual pain (dysmenorrhea, DYS) and the nonmenstrual pelvic pain (NMPP). These important results have been announced by AbbVie in cooperation with Neurocrine Biosciences Inc. (NBIX) since Neurocrine licensed the worldwide rights to elagolix to Abbott Labs in June 2010.
Endometriosis is a disease in which tissue that normally lines the inside of the uterus grows outside the uterus and most commonly involves the ovaries, fallopian tubes and the tissue lining the pelvis. The disease can cause pain and may develop fertility problems.
In the first study and second pivotal Phase 3 study, results from patients treated with elagolix compared with the placebo group were quite similar at the third month.
In essence the percentage of DYS responders was higher than the percentage of NMPP responders to two different therapies, compared with the placebo group –Â 150 milligrams of elagolix once daily (46 DYS out of 100 patients versus 20% of patients in the placebo group and 50 NMPP out of 100 patients versus 36% of patients in the placebo group ) and 200 milligrams of elagolix twice daily (76 DYS out of 100 patients versus 20% of patients in the placebo group and 55 NMPP out of 100 patients versus 36% of patients in the placebo group).
Concerning the safety profile of elagolix, results on adverse events were consistent across Phase 3 trials and with prior studies on this medication.
"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. Elagolix is currently being investigated in diseases that are mediated by sex hormones, such as uterine fibroids and endometriosis." (ABBV's PR).
AbbVie plans to submit a new drug application to the U.S. Food and Drug Administration (FDA) for endometriosis in 2017.
On Oct. 19, AbbVie closed at $61.43 per share on the New York Stock Exchange. The trailing price-earnings (P/E) is 17.72, the price-book (P/B) (mrq) is 17.74 and return on equity (ttm) is 102.66%.
Disclosure: I have no positions in AbbVie.
Start a free seven-day trial of Premium Membership to GuruFocus.
