Corcept Therapeutics Incorporated (CORT) announced the commencement of its Phase 3 trial with CORLUX for the treatment of endogenous Cushing's Syndrome. CORLUX is a cortisol receptor (GR-II) antagonist. The FDA indicated that a single study may provide a reasonable basis for the submission of a New Drug Application. Corcept previously received Orphan Drug Designation for CORLUX for the treatment of endogenous Cushing's Syndrome.
Cushing's Syndrome is caused by prolonged exposure of the body's tissues to high levels of the hormone cortisol. Cushing's Syndrome is relatively rare and most commonly affects adults aged 20 to 50. Symptoms vary, but most people have one or more of the following manifestations: High blood sugar, high blood pressure, upper body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are common. Cushing's Syndrome can affect every organ system in the body and can be lethal if not treated effectively.
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