FDA CLEARS EXPANDED COMPATIBILITY FOR INOMAX® DRUG-DELIVERY SYSTEMS
-- INOMAX® DS and INOMAX® DSIR Now Compatible with Nearly 60 Respiratory Care Devices --
Hampton, NJ, March 21, 2012 – Ikaria, Inc., a critical care company focused on developing and commercializing innovative therapies for critically ill patients, today announced that the Center for Devices and Radiological Health (CDRH) branch of the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for compatibility of its INOMAX drug-delivery systems with three additional respiratory care devices. The INOMAX DS and the INOMAX DSIR have now been validated with nearly 60 makes of ventilators, anesthesia systems and other respiratory care devices.
The INOMAX DS and INOMAX DSIR are proprietary drug-delivery systems that deliver INOMAX® (nitric oxide) for inhalation, the only drug approved by the FDA to treat hypoxic respiratory failure (HRF) associated with pulmonary hypertension in term and near-term infants greater than 34 weeks gestational age. HRF is a serious condition in which blood vessels in the lungs constrict, making it difficult to oxygenate blood. INOMAX selectively relaxes pulmonary blood vessels, improves oxygenation and treats HRF in this fragile newborn population.
The FDA's clearance of these additional respiratory care devices for use with the INOMAX DS and INOMAX DSIR makes Ikaria's INOMAX drug-delivery systems fully compatible with the most commonly used invasive mechanical ventilation methods and non-invasive respiratory strategies in neonatal intensive care units (NICUs), including continuous positive airway pressure (CPAP) and nasal cannulae. This represents Ikaria's ongoing commitment to meet the needs of its customers by providing clinicians with the flexibility to safely deliver INOMAX to critically ill patients using many ventilation strategies.
The INOMAX drug-delivery systems are now compatible with the Fisher & Paykel Healthcare Bubble CPAP System and the Hamilton-C2 and Hamilton-G5 ventilators. For a complete list of ventilators, anesthesia systems and other respiratory care devices with which INOMAX drug-delivery systems have been validated, please visit www.inomax.com.
The INOMAX DS and INOMAX DSIR drug-delivery systems are part of a comprehensive offering known as the INOMAX therapy package. In addition to use of Ikaria's proprietary, FDA-cleared drug-delivery systems, the INOMAX therapy package includes INOMAX (nitric oxide) for inhalation, distribution, emergency delivery, technical and clinical assistance, quality maintenance, on-site hospital training, 24/7/365 customer service, and all related disposable items.
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.
INOMAX should not be used in the treatment of neonates known to be dependent on right-to-left shunting of blood. Abrupt discontinuation of INOMAX may lead to a worsening condition. Methemoglobinemia is a dose-dependent side effect of inhaled nitric oxide therapy. Nitrogen dioxide (NO2) forms rapidly in gas mixtures containing nitric oxide and oxygen, and therefore may cause airway inflammation and damage. Methemoglobin, NO2, and FiO2 should be monitored during nitric oxide administration.
Please see prescribing information. For additional information about INOMAX, please visit www.inomax.com.
About Ikaria, Inc.
Ikaria, Inc. is a critical care company focused on developing and commercializing innovative therapies designed to address the significant needs of critically ill patients. The company's lead product is INOMAX® (nitric oxide) for inhalation, the only FDA-approved drug for the treatment of hypoxic respiratory failure associated with pulmonary hypertension in term and near-term infants. It is offered through the INOMAX therapy package, an all-inclusive offering of drug product, drug-delivery system, on-site training and 24/7/365 technical assistance and support. The INOMAX therapy package also is marketed in Puerto Rico, Canada, Australia, Mexico and Japan. The company is investigating additional indications for INOMAX in bronchopulmonary dysplasia, and for inhaled nitric oxide with the INOpulse® DS drug-delivery system as a drug-device combination product in pulmonary arterial hypertension (PAH) and chronic obstructive pulmonary disease (COPD). Ikaria's late-stage pipeline is also comprised of LUCASSIN® (terlipressin), a potential treatment for Hepatorenal Syndrome Type 1; as well as Bioabsorbable Cardiac Matrix (BCM), a potential treatment for preventing cardiac remodeling and subsequent congestive heart failure following acute myocardial infarction. Ikaria is headquartered in Hampton, NJ, with a research facility in Madison, WI and manufacturing facilities in Port Allen, LA and Madison, WI. Please visit www.ikaria.com.