Oriahnn is a combination oral therapy containing three active ingredients: elagolix (a gonadotropin-releasing hormone [GnRH] receptor antagonist), estradiol (an estrogen), and norethindrone acetate (a synthetic progestin). Elagolix suppresses pituitary GnRH receptors, reducing the secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), thereby lowering ovarian production of estrogen and progesterone. The inclusion of estradiol and norethindrone acetate is likely designed to mitigate hypoestrogenic effects (e.g., bone mineral density loss) associated with prolonged GnRH antagonist use, while providing endometrial protection against unopposed estrogen stimulation.

This supplemental approval addresses an alternative blister pack configuration to simplify packaging, enhancing patient usability. While the document does not specify the approved indication, elagolix-based therapies are historically indicated for conditions such as endometriosis-associated pain, where hormonal modulation is critical. The combination of estradiol and norethindrone acetate suggests a targeted approach to balance efficacy and tolerability. Clinicians should adhere to the most recent prescribing guidelines for dosing, contraindications, and monitoring parameters, which are not detailed in this correspondence.