Pituitary World News (PWN), a not-for-profit news and patient advocacy organization that seeks to raise awareness of pituitary disease and related illnesses, conducted an in-depth interview with Maria Fleseriu, M.D., FACE, professor of Medicine and Neurological Surgery and director of the Oregon Health Sciences University Pituitary Center and principal investigator of the SONICS and LOGICS studies.
The discussion addresses a range of Cushing’s syndrome topics, including the latest advances in medical treatments, new therapies on the horizon, key results from both the LOGICS and SONICS Phase 3 studies of RECORLEV, and the associated challenges and unmet needs in the diagnosis and treatment of the disease.
RECORLEV (levoketoconazole) is the pure 2S,4R enantiomer of ketoconazole, a steroidogenesis inhibitor used to treat endogenous Cushing’s syndrome. Ketoconazole is recommended for use in treating Cushing's syndrome,1 but is not approved for that use in the US. We believe that RECORLEV (levoketoconazole) may have favorable efficacy, safety, and tolerability for patients with endogenous Cushing’s syndrome.
Levoketoconazole is currently being evaluated in phase 3 trials for patients with endogenous Cushing’s syndrome.
The safety and efficacy of RECORLEV (levoketoconazole) for treatment of endogenous Cushing’s syndrome have not been established.
Additional Information on the LOGICS study
*Cortendo AB (Cortendo), a subsidiary of Strongbridge Biopharma plc, is the sponsor of the LOGICS trial.
The SONICS study, now completed, assessed normalization of mUFC at the end of 6 months of maintenance therapy.
The safety and efficacy of RECORLEV (levoketoconazole) for treatment of endogenous Cushing’s syndrome have not been established.
Additional Information on the SONICS study
*Cortendo AB (Cortendo), a subsidiary of Strongbridge Biopharma plc, is the sponsor of the SONICS trial.
The OPTICS study, currently recruiting, is an open-label extension study in those who previously completed either the LOGICS trial, the SONICS trial, or both.
The safety and efficacy of RECORLEV (levoketoconazole) for treatment of endogenous Cushing’s syndrome have not been established.
Additional Information on the OPTICS study
*Cortendo AB (Cortendo), a subsidiary of Strongbridge Biopharma plc, is the sponsor of the OPTICS trial.
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