GeNO LLC announced that the FDA has granted orphan drug designation for its inhaled nitric oxide (delivered via the GeNOsyl MVG-2000 delivery system) for the treatment of persistent pulmonary hypertension in newborns (PPHN). 

The orphan drug designation was granted based on a plausible hypothesis for clinical superiority over the approved nitric oxide product.

Nitric oxide relaxes vascular smooth muscle and when inhaled produces pulmonary vasodilation. Infants with PPHN have a high pulmonary vascular resistance leading to hypoxemia. Nitric oxide improves oxygenation.

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