Ohmeda NO2 trials for neonatal PPH should not use improved oxygenation as primary endpoint -- FDA cmte.

Executive Summary

OHMEDA NITRIC OXIDE TRIALS FOR NEONATAL PPH SHOULD NOT USE IMPROVED OXYGENATION as the primary endpoint, FDA's Cardiovascular & Renal Drugs Advisory Committee determined at its Aug. 28 meeting. The meeting was devoted to a discussion of guidelines for the development of inhaled nitric oxide for the treatment of persistent pulmonary hypertension of newborns, although the crux of the discussion was Ohmeda's choice of a primary endpoint for its clinical trial of inhaled nitric oxide for the condition. The committee voted unanimously that Ohmeda's proposed time-weighted oxygenation index is not an acceptable primary endpoint.