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news.Ikaria, a critical care company, has concluded patient enrollment into its pivotal Phase III trial evaluating the use of inhaled nitric oxide (iNO) in premature infants with bronchopulmonary dysplasia (BPD).
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iNO is available as Inomax (nitric oxide) for inhalation, that selectively relaxes the cells of the pulmonary vasculature, resulting in increased blood flow through the lungs and delivery of oxygenated blood to the body.
In conjunction with ventilation and other appropriate agents, iNO treats term and near-term newborns with hypoxic respiratory failure associated with evidence of pulmonary hypertension.
The study entitled, Inhaled Nitric Oxide for the Prevention of Bronchopulmonary Dysplasia in Preterm Infants, or the "NewNO Trial," administered eligible subjects with iNO at a starting dose of 20ppm for a duration of 24 days.
The multi-center double blind placebo-controlled randomized clinical trial is intended to determine whether preterm infants who require mechanical ventilation or positive pressure support at any point during days 5 to 14 after birth may benefit from treatment with iNO.
Ikaria chairman and CEO Daniel Tasse said the data from this trial will provide the definitive answers the medical community has been seeking, particularly in light of the recommendations generated by the 2010 NIH Consensus Conference on BPD.
The company said Inomax is not yet approved for use in BPD.