New data strengthens Strongbridge's case for Recorlev in Cushing's syndrome

Rare diseases specialist Strongbridge Biopharma (Nasdaq: SBBP) has announced top-line findings from the extended evaluation phase of the Phase III SONICS study of Recorlev (levoketoconazole) for the potential treatment of endogenous Cushing’s syndrome.

The purpose of the six-month extended evaluation phase was to evaluate the long-term safety, tolerability and benefit-risk during chronic use of Recorlev.

Treatment with the drug was associated with no new clinically relevant liver-related findings or other new safety signals, while demonstrating long-term efficacy to reduce mean urinary free cortisol, as well as key cardiovascular risk markers such as weight and LDL-cholesterol.