STAINES-UPON-THAMES, United Kingdom, Aug. 1, 2017 /PRNewswire/ -- Mallinckrodt Pharmaceuticals (NYSE: MNK), a leading global specialty pharmaceutical company, today confirmed inclusion of the first patient in the company's Phase 4 registry assessing the use of INOMAX® (nitric oxide) gas for inhalation for premature (less than 34 weeks gestational age) neonates versus term and near-term neonates (greater than 34 weeks gestational age).
"We are pleased to enroll the first patient in this multicenter, observational registry, which will generate data and insights concerning inhaled nitric oxide use in preterm neonates with pulmonary hypertension compared with term and near-term neonates with pulmonary hypertension," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt.
INOMAX is approved by the U.S. Food and Drug Administration (FDA) for use to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term neonates (at 34 weeks and greater gestational age) with hypoxic respiratory failure (HRF) associated with pulmonary hypertension (PH) in conjunction with ventilatory support.
About the Registry
The Phase 4 registry is titled "Multicenter, Prospectively Defined Observational Registry With Retrospective Data Collection, Evaluating Premature and Term-Near-Term Neonates With Pulmonary Hypertension Receiving Inhaled Nitric Oxide via Invasive or Noninvasive Ventilator Support at U.S. Centers" or the "Registry Evaluating Premature and Term-Near-Term Neonates With Pulmonary Hypertension Receiving Inhaled Nitric Oxide (PaTTerN)" trial. Data collected from this registry will increase understanding of the potential utility of inhaled nitric oxide for controlling PH and improving oxygenation in pre-term neonates with HRF associated with PH compared to term and near-term neonates with HRF associated with PH.
The primary outcome measure will compare the incidence of subjects with at least a 25 percent improvement in Oxygenation Index or Surrogate Oxygenation Index (for subjects who are not ventilated), compared to baseline and summarized by gestation age group. Estimated enrollment for this study is 168 patients, with completion expected by 2022.
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 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. Despite the diversity of causes, marked pulmonary vasoconstriction is the central pathophysiologic feature of PPHN. 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.
In the U.S., INOMAX is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with HRF associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.
Important Safety Information
INOMAX is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood.
Abrupt discontinuation of INOMAX may lead to increasing pulmonary artery pressure and worsening oxygenation.
Methemoglobinemia and NO2 levels are dose dependent. Nitric oxide donor compounds may have an additive effect with INOMAX on the risk of developing methemoglobinemia. Nitrogen dioxide may cause airway inflammation and damage to lung tissues.
In patients with pre-existing left ventricular dysfunction, INOMAX may increase pulmonary capillary wedge pressure leading to pulmonary edema.
Monitor for PaO2, methemoglobin, and inspired NO2 during INOMAX administration.
INOMAX must be administered using a calibrated INOmax DSIR® Nitric Oxide Delivery System operated by trained personnel. Only validated ventilator systems should be used in conjunction with INOMAX.
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies. 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; and analgesics and hemostasis products. The company's core strengths include the acquisition and management of highly regulated raw materials and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines and its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing. To learn more about Mallinckrodt, visit http://www.mallinckrodt.com/.
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