Questcor To Commence Acthar Phase 2 Study - Quick Facts

(RTTNews) - Questcor Pharmaceuticals, Inc. (QCOR) announced it will commence a Phase 2 study to explore the efficacy and safety of H.P. Acthar Gel (repository corticotropin injection) for Acute Respiratory Distress Syndrome. The company's Investigational New Drug (IND) application for the study has been reviewed by the U.S. FDA and is now active.

The study will seek to enroll up to 210 patients in a 4-week randomized, placebo controlled trial designed to explore the efficacy and safety of several dosing regimens of Acthar in patients with moderate to severe ARDS. The primary objective of the study will be to determine if Acthar increases the number of ventilator-free days during the 28-day treatment period. Secondary endpoints include whether Acthar therapy diminishes mortality, organ failure and the length of hospital or ICU stay.