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news.The US Food and Drug Administration (FDA) has granted orphan drug designation for the use of Ikaria's inhaled nitric oxide (iNO) with the INOpulse DS drug-delivery system to treat pulmonary arterial hypertension (PAH).
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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.
Nitric oxide inhalations can selectively relax the cells of the pulmonary vasculature, resulting in increased blood flow through the lungs and delivery of more oxygenated blood to the body.
Ikaria chairman and CEO Daniel Tasse said the receipt of orphan drug designation for the use of iNO via the INOpulse in PAH, combined with the IND marks the progress of the company’s late-stage pipeline.
"We’re delighted to have PAH and bronchopulmonary dysplasia as additional indications under investigation for iNO, and also are planning its investigation with the INOpulse DS in chronic obstructive pulmonary disease," Tasse added.
The company has submitted an investigational new drug application (IND) for PAH to the FDA in November 2011.