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Consistent with previously reported six month (Petal study) and three month (Lilac Petal study) results, a favorable safety profile and clinically meaningful efficacy have again been confirmed through month six of the Lilac Petal study.
According to Neurocrine, this newly available data also provides clinical confirmation of Neurocrine's extensive pharmacologic modeling related to the elagolix dose-response continuum. The outcome of primary interest at month six was the impact of the elagolix 250mg dose on bone mineral density (BMD) as measured by dual energy X-ray absorptiometry scanning.
Over the six month treatment period, elagolix 150mg once daily had minimal impact on BMD (-0.80% mean change from baseline, femur; -0.66% mean change from baseline, spine). The 250mg once daily dose, as expected, had slightly greater percentage change from baseline at month six (-1.0% femur, -1.6% spine). The 150mg once daily BMD profile in this Lilac Petal study is consistent with that previously demonstrated in the six-month Petal study.
From an efficacy standpoint, the exploratory daily pain scales for dysmenorrhea and non-menstrual pelvic pain demonstrated that women had minimal endometriosis pain symptoms at month six. The overall assessment of benefit using the patient global impression of change revealed that 80% of elagolix 150mg subjects and 79% of elagolix 250mg subjects were 'much improved' or 'very much improved' after six months of treatment, Neurocrine said.
Subjects treated with elagolix also reported considerable improvement on the endometriosis health profile (EHP-5), a validated endometriosis-specific scale which reveals the impact of treatment on a variety of health outcome domains. The core pain dimension of the EHP-5 documented the marked improvement of endometriosis-related pain and its impact on daily function for both doses of elagolix.
The symptom improvement demonstrated by all of the efficacy assessments was maintained over the entire study duration and consistent with results across the entire Phase II program.
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