Ikaria, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted INOMAX® (nitric oxide) for inhalation an additional six months of marketing exclusivity, known as "pediatric exclusivity." The action extends exclusivity for INOMAX from January 2013 to July 2013. This decision was based on data submitted from three clinical trials of INOMAX in pre-term infants at risk for bronchopulmonary dysplasia (BPD), a serious respiratory condition resulting from lung injury.
Data from three large, multi-center, double-blind, placebo-controlled clinical trials examining the efficacy and safety of INOMAX in pre-term infants less than or equal to 34 weeks gestational age were submitted to the FDA. Although the safety and tolerability of INOMAX has been shown in these trials, substantial evidence of efficacy has not been demonstrated. Therefore, Ikaria continues to study the efficacy of INOMAX for the prevention in BPD in pre-term infants through its Phase III clinical trial, which commenced in December 2009. INOMAX is not indicated for the prevention of BPD in pre-term infants.
INOMAX is indicated for the treatment of hypoxic respiratory failure, or HRF, in term and near-term (greater than 34 weeks) infants. HRF occurs when the cells in the body are unable to receive enough oxygen, and is a life-threatening condition for newborns. INOMAX helps critically ill newborns breathe more effectively by dilating the blood vessels of the lungs, which improves oxygen uptake and maximizes oxygen supply to the tissues of the body. Use of INOMAX reduces the need for extracorporeal membrane oxygenation (ECMO), a highly-invasive and expensive surgical procedure in which an infant's blood is mechanically oxygenated by connecting the newborn to a heart-lung machine.
INOMAX is delivered as part of a comprehensive offering known as INOtherapy®. In addition to INOMAX, INOtherapy includes use of Ikaria's proprietary, FDA-cleared drug-delivery system, all related disposable items, distribution, emergency delivery, technical and clinical assistance, quality maintenance, on-site hospital training, and 24/7/365 customer service.