FDA Clears INOMAX® DSIR To Connect With Hospital Health Information Systems

HAMPTON, N.J., Nov. 13, 2012 /PRNewswire/ -- 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 a software upgrade to enable connectivity of the INOMAX^® DSIR drug delivery system with hospital health information systems.

This connectivity allows data regarding INOMAX^® usage to be transmitted directly to electronic medical records where it can easily be viewed at computer stations to reduce charting time, avoid transcription errors, and improve billing efficiency.  This feature, which is aligned with the effort by major health systems to automate and capture patient data, also facilitates reimbursement for INOMAX usage.

Additionally, the FDA has cleared three new, non-invasive respiratory care devices for use with the INOMAX^® DS and DSIR drug-delivery systems -- the Fisher & Paykel Healthcare Infant Circuit Nasal Cannula and Optiflow™ Breathing Circuit and the A-Plus Medical Babi Plus™ Bubble CPAP.  Sixty ventilators, anesthesia systems and other respiratory care devices have now been validated for use with Ikaria's INOMAX DS and DSIR drug-delivery systems.  This represents almost all FDA-cleared ventilation strategies used in neonatal intensive care units (NICUs) throughout the United States.

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.

These FDA clearances represent Ikaria's ongoing commitment to meet the needs of its customers by offering features that assist them in patient care, data reporting, and billing and reimbursement, and to provide clinicians with the flexibility to safely deliver INOMAX to critically ill patients using almost any FDA-cleared ventilation strategy.

The INOMAX DS and INOMAX DSIR drug-delivery systems are part of a comprehensive offering that, in addition to use of Ikaria's proprietary, FDA-cleared drug-delivery systems, 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.

A complete list of ventilators, anesthesia systems and other respiratory care devices with which INOMAX drug-delivery systems are validated, as well as additional information about INOMAX, can be found at www.inomax.com.

About INOMAX^®  
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. 

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 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 pulmonary hypertension secondary to chronic obstructive pulmonary disease (COPD). Ikaria's late-stage pipeline is also comprised of terlipressin, a potential treatment for Hepatorenal Syndrome Type 1 that is approved in Australia as LUCASSIN^®, 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 research facilities in North Brunswick, NJ and Madison, WI and manufacturing facilities in Port Allen, LA and Madison, WI.  Please visit www.ikaria.com.

SOURCE Ikaria, Inc.