Mallinckrodt announces prelim results from Phase 4 registry for INOmax gas

Mallinckrodt announced preliminary results of a planned interim analysis from the company’s Phase 4 registry assessing the use of INOmax gas, for inhalation, for premature neonates versus term and near-term neonates with pulmonary hypertension, or PH. The primary outcome measure compares the incidence of mechanically ventilated subjects with PH who achieve at least a 25% improvement in Oxygenation Index, or OI, from baseline, or Surrogate Oxygenation Index, or SOI, for subjects who are not ventilated, between gestation age groups. OI is commonly used to evaluate the severity of hypoxic respiratory failur, or HRF, in neonates with PH. The planned interim analysis occurred at the approximate midway point of enrollment. The preliminary analysis found that, at this juncture in the study, approximately 86% of both cohorts showed a 25% or greater improvement in OI or SOI during the treatment period. The safety and efficacy of INOmax nitric oxide gas for treating HRF in premature neonates with PH has not been evaluated by the FDA.

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