Data from two replicate phase III studies evaluating the efficacy and safety of elagolix is published today in the New England Journal of Medicine, and presented at the 13th World Congress on Endometriosis.
Two similar, double-blind, 6-month randomised controlled trials were conducted in 1,689 women to evaluate the response to two different doses, 150mg (n=872) and 200mg (n=817) respectively, across 338 sites on five continents.
As highlighted by Professor Hugh Taylor, lead author of the resulting paper, physicians currently have limited options for the long-term medical management of endometriosis and are in need of additional treatment options to help manage the condition.
The results of these two replicate phase II studies highlighted the efficacy and safety profile of elagolix, and demonstrated its potential to be an important treatment option for women with endometriosis.
Said Professor Taylor:
The idea that we now have choices with regards to the extent of oestrogen suppression is attractive, as it allows us to provide a more personalised and individualised therapy.
With elagolix – unlike with Lupron – we can partially suppress oestrogen, unlike the “all or nothing” current approach.
With the two different doses we can suppress oestrogen levels to just what the individual needs to control her endometriosis without necessarily having the menopausal side effects we see with a GnRH-agonist.
Taylor HS, et al. Treatment of endometriosis-assocaited pain with elagolix, an oral GnRH antagonist. NEJM 2017 [ePub].
Elagolix is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist – a short-acting molecule that blocks endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland. Administration results in rapid, reversible, dose-dependent inhibition of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion, leading to reduced ovarian production of the sex hormones, oestradiol and progesterone, while on therapy. Elagolix is currently being investigated in uterine fibroids and endometriosis, and has been studied in over 40 clinical trials totalling more than 3,000 women. AbbVie, the makers of the drug, plans to submit a New Drug Application to the US Food and Drug Administration (FDA) for endometriosis in 2017.