In a press release, Strongbridge Biopharma announced comprehensive positive results of their Phase 3 SONICS study of RECORLEVTM (levoketoconazole) for the potential treatment of endogenous Cushing’s syndrome. The results were published online in The Lancet Diabetes & Endocrinology.
According to the release – DUBLIN, Ireland and TREVOSE, Pa., Sept. 19, 2019 (GLOBE NEWSWIRE) – “The Phase 3 SONICS study demonstrated RECORLEV, the 2S,4R enantiomer of ketoconazole, was safe and effective in a representative population of patients with endogenous Cushing’s syndrome,” said Maria Fleseriu, M.D., FACE, Professor of Medicine and Neurological Surgery and director of the Oregon Health Sciences University Northwest Pituitary Center and principal investigator of the study. “Importantly, treatment with RECORLEV was shown to be effective for reducing and normalizing mUFC (mean urinary free cortisol) concentrations and biomarkers of cardiovascular risk, as well as improving clinical signs and quality of life in patients with endogenous Cushing’s syndrome. These data are highly encouraging, given medical needs.
“These results are encouraging”, said Dr. Lewis Blevins, Pituitary World News cofounder, Medical Director, California Center for Pituitary Disorders at UCSF and Professor of Clinical Medicine and Clinical Neurological Surgery,” and illustrate that this new drug will likely play an important role in the management of hypercortisolism. I expect that it will supplant the use of ketoconazole, a drug that is not approved by the US Food and Drug Administration for hypercortisolism and is associated with a significant risk of hepatotoxicity.”
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