INOmax is indicated for the treatment of term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension. The safety and efficacy of INOmax in premature neonates has not been evaluated by the
Persistent pulmonary hypertension of the newborn (PPHN) is a serious and sometimes fatal cardiorespiratory complication of the transition to extra-uterine life.1,2 The registry trial was conducted to examine the utility of INOmax in pre-term neonates. Due to the seriousness of the condition, a randomized controlled trial cannot be conducted in the pre-term neonate population.
"Mallinckrodt is extremely pleased to be able to end this registry based on positive findings much earlier than anticipated," said
The observational registry study was conducted across 31 sites and was designed to evaluate the effectiveness and safety of INOmax in 168 premature neonates vs term and near-term neonates (1:1) with PH. The interim analysis assessed 54 premature and 84 term and near-term neonates and demonstrated that the trial achieved the significance level for non-inferiority. Evaluation of significant improvement for each neonate is based on at least a 25 percent decrease in oxygenation index (OI) or surrogate
No drug-related serious adverse events were attributed to study drug. At the time of the interim analysis, there were 17 adverse events of special interest reported in 16 subjects, most of which were in the preterm group and deemed not related or unlikely related to study drug.
INOmax has been on the market in the
About the Observational Registry
More information about the trial can be found here.
The current study is a prospective observational registry that collects real world data that describes how INOmax nitric oxide gas is being used in clinical practice. As an observational study it does not utilize placebo. Hence, some of the improvement observed in the current study could be due to factors other than treatment with INOmax. Similarly, without placebo control it is not possible to understand the magnitude to which patients who experienced limited response to inhaled nitric oxide would have otherwise decompensated without this treatment.
About Persistent Pulmonary Hypertension of the Newborn (PPHN)
PPHN is a serious and sometimes fatal cardiorespiratory complication of the transition to extra-uterine life.1,2 PPHN is a clinical syndrome associated with various neonatal cardiorespiratory diseases, including meconium aspiration, respiratory distress syndrome (hyaline membrane disease), congenital heart disease and congenital hernia.1 Despite the diversity of causes, marked pulmonary vasoconstriction is the central pathophysiologic feature of PPHN.3 The most significant hemodynamic feature in neonates with severe hypoxia is a pulmonary-to-systemic pressure imbalance. Treatment in these neonates is directed toward lowering the pulmonary vascular pressure and supporting the systemic circulation.1,3
INOmax® (nitric oxide) gas, for inhalation, is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.
IMPORTANT SAFETY INFORMATION
Please see Full Prescribing Information.
Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
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CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements concerning inhaled nitric oxide ("iNO") and the Company's iNO product, including statements with regard to the clinical data generated in the study described above. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the
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1Nair J, Lakshminrusimha S. Update on PPHM: Mechanisms and treatment. Semin Perinatol. 2014;38(2):78-91.
2Clark RH. The epidemiology of respiratory failure in neonates born at an estimated gestational age of 34 weeks or more. J Perinatol. 2005;25(4):251-257.
3Wedgwood S, Steinhorn RH, Lakshminrushimha S. Optimal oxygenation and role of free radicals in PPHN. Free Radical Biology and Medicine. 2019;142:97-106.
4Lakshminrusimha S. The pulmonary circulation in neonatal respiratory failure. Clin Perinatol. 2012;39(3):655-683.
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