Ikaria has completed patient enrolment in its pivotal Phase III clinical trial investigating the use of inhaled nitric oxide (iNO) in premature infants with bronchopulmonary dysplasia (BPD).
Inhaled nitric oxide is available as Inomax for inhalation, which in combination with ventilation and other appropriate agents, treats term and near-term newborns with hypoxic respiratory failure associated with evidence of pulmonary hypertension.
iNO selectively relaxes the cells of the pulmonary vasculature, resulting in increased blood flow through the lungs and delivery of oxygenated blood to the body.
The multi-centre double blind placebo-controlled randomised clinical trial, entitled, Inhaled Nitric Oxide for the Prevention of Bronchopulmonary Dysplasia in Preterm Infants, or the NewNO Trial, administered subjects with iNO at a starting dose of 20ppm for a duration of 24 days.
The aim of the trial is 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.
The study includes a one-year follow-up assessment, as discussed with the US Food and Drug Administration (FDA).
Ikaria chairman and CEO Daniel Tasse said: ‘We are hopeful that 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 firm said Inomax should not be used in the treatment of neonates known to be dependent on right-to-left shunting of blood.
In January 2012, the FDA granted orphan drug designation for the use of iNO with the INOpulse DS drug-delivery system as a combination product for treating pulmonary arterial hypertension (PAH).
Inomax is not yet approved for use in BPD, the company said.
Headquartered in Hampton, US, Ikaria is a critical care company focused on developing and commercialising innovative therapies designed to address the significant needs of critically ill patients.