Orphan Drug Designation for Inhaled Nitric Oxide in Pulmonary Arterial Hypertension

Ikaria, Inc. announced that the FDA has granted orphan drug designation for the use of inhaled nitric oxide (iNO) with the INOpulse DS drug-delivery system as a combination product for pulmonary arterial hypertension (PAH). An investigational new drug application (IND) for PAH was submitted to the FDA in November 2011, and the company is pursuing clinical development under this open IND.

Inhaled nitric oxide is available as INOmax (nitric oxide) for inhalation. The delivery of iNO will be pulsed to synchronize with the patient's breathing pattern through Ikaria's next-generation INOpulse DS drug-delivery system, which is specially engineered for use in spontaneously breathing patients. Ikaria's PAH development program, known as IK-7001, will investigate the use of iNO/INOpulse DS as a drug-device combination product.

INOmax is a vasodilator, which, in conjunction with ventilator support and other appropriate agents, is indicated for the treatment of term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, where it improves oxygenation and reduces the need for extracorporeal membrane oxygenation.

For additional information, call (877) 566-9466 or visit www.ikaria.com.