Neurocrine Biosciences announced additional positive safety and efficacy results from its Phase 2b trial (the Petal Study) for elagolix to treat patients with endometriosis. The primary endpoint, impact on bone mineral density (BMD), was met at Week 24. Additionally, Neurocrine confirmed a favorable bone safety profile at Week 48 with no cumulative reduction in BMD evident. Furthermore, patients reported sustained improvement in pain reduction (as measured by the Composite Pelvic Signs and Symptoms Score (CPSSS)) and in quality of life (as measured by the Endometriosis Health Profile (EHP-5)).
The previously reported pharmacodynamic effects of elagolix were confirmed. Median estradiol values were maintained in the low baseline range while on treatment and, most importantly, were not lowered to values that would be associated with hot flashes or clinically significant bone loss. The mean time to ovulation post-treatment was 24 days for women who had been randomized to elagolix and >90% of subjects had evidence of ovulation within 4 weeks of stopping.
Elagolix is an orally-active non-peptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist.
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