Strongbridge Biopharma plc Announces Positive Top-Line Results from the Pivotal Phase 3 SONICS Study of RECORLEV™ (levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome
Press release originally posted on Strongbridgebio.com
~ SONICS Study Met Primary Endpoint with RECORLEV Demonstrating a Statistically Significant Normalization Rate of Urinary Free Cortisol at Six Months ~
~ Key Secondary Endpoints Evaluating Cardiovascular Risk Markers Showed Statistically Significant and Clinically Meaningful Improvements from Baseline ~
~ RECORLEV was Generally Well Tolerated with Only 3.2 Percent of Patients Demonstrating an Increase in Alanine Aminotransferase Measurement of Greater Than Five Times the Upper Limit of Normal~
~ Strongbridge Plans to Discuss Potential for Accelerated Approval of RECORLEV with FDA ~
DUBLIN, Ireland and TREVOSE, Pa., Aug. 08, 2018 (GLOBE NEWSWIRE) -- Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced top-line results from the multinational, pivotal Phase 3 SONICS study evaluating RECORLEV™ (levoketoconazole) for the treatment of endogenous Cushing’s syndrome.