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Diurnal Ltd., a Neurocrine Biosciences Company, Presents Phase 3 Extension Study Data for Modified-Release Hydrocortisone in Patients with Congenital Adrenal Hyperplasia at ENDO 2023
SAN DIEGO, June 15, 2023 /PRNewswire/ -- Diurnal Ltd., a Neurocrine Biosciences company (Nasdaq: NBIX), today announced that it will present new post hoc
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[{"type":"text","content":"SAN DIEGO, June 15, 2023 /PRNewswire/ -- Diurnal Ltd., a Neurocrine Biosciences company (Nasdaq: NBIX), today announced that it will present new post hoc analyses of Phase 3 extension study data for modified-release hydrocortisone (approved as EFMODY® in United Kingdom and European Union), which is being investigated as a treatment for adults with congenital adrenal hyperplasia (CAH), at ENDO 2023 June 15–18 in Chicago. Diurnal Ltd. developed this modified-release formulation of hydrocortisone, which has been specifically designed to replicate the natural circadian release of cortisol.\n\n \n \n \n \n \n \n\n \nManagement of CAH involves not only replacing cortisol deficiency but also managing elevated adrenal androgen levels, which are responsible for the detrimental symptoms associated with hyperandrogenism, such as virilization in females and abnormalities in growth leading to short stature and early puberty. Current treatment guidelines recommend a target daily hydrocortisone dose of ≤25 mg (or equivalent dose of prednisone, prednisolone, or dexamethasone) in adult (fully grown) patients with CAH. However, hydrocortisone doses of >25 mg are often necessary to lower adrenal androgens in CAH. Thus, physicians treating CAH patients typically face a difficult dilemma of trying to manage the androgen excess while also trying to avoid the well-known consequences of chronic glucocorticoid overexposure.\nThe post hoc analyses examined total glucocorticoid daily dose and 9:00 a.m. 17-hydroxyprogesterone (17-OHP) levels in patients treated with modified-release hydrocortisone in an open-label Phase 3 extension study. Of the 71 patients who completed 24 months in the Phase 3 extension study at the time of the interim cut, 64 patients had 9:00 a.m. 17-OHP data for analysis. After 24 months of treatment, median daily hydrocortisone dose was reduced from 30 mg to 20 mg. The number of patients achieving lower androgen levels while receiving ≤25 mg of hydrocortisone per day increased significantly, with 48 percent of the subjects achieving 17-OHP levels","length":3018,"tagName":"div"}]