Discovery Laboratories Gets FDA Clearance For Phase II Study Of AEROSURF

(RTTNews) - Discovery Laboratories, Inc. (DSCO) Tuesday said its investigational new drug (IND) application for AEROSURF has been cleared by the U.S. Food and Drug Administration, or FDA, for initiating the phase 2 clinical program.

AEROSURF is a novel investigational drug which is indicated for the treatment of respiratory distress syndrome in premature infants without invasive endotracheal intubation.

The phase 2 clinical program is expected to include two studies - one to evaluate the safety and tolerability of a single exposure of aerosolized KL4 surfactant drug product, and the second to determine the the optimal dose and efficacy margin of the drug.