Mallinckrodt announced that the phase 4 observational registry study evaluating INOmax® (nitric oxide) gas, for inhalation, in preterm neonates with pulmonary hypertension was stopped early due to “achievement of the pre-specified primary outcome measure, noninferiority.”
INOmax gas, for inhalation, is currently indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term neonates (>34 weeks gestation) with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.
The multicenter, prospectively defined, observational registry study (PaTTerN) compared the efficacy and safety of INOmax in 84 preterm neonates (27 to <34 weeks gestational age) to 84 term and near-term neonates (34 to 40 weeks gestational age). The primary end point of the study was the incidence of patients with ≥25% improvement from baseline in oxygenation index (OI) or surrogate oxygenation index (SOI) in preterm vs near-term neonates.
Interim analysis assessed 54 premature and 84 term and near-term neonates. Findings demonstrated that the study achieved statistical significance for noninferiority in premature neonates compared to term and near-term neonates (95% CI: -0.0021, 0.1158; with a predefined margin of -0.1452).
There were 17 reported adverse events, most of which were in premature neonates and were not related or unlikely related to INOmax, according to the Company. There were no serious drug-related adverse events.
Additional study results are expected to be presented at a future scientific forum.
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