Revatio fails in Phase III study of newborns with persistent pulmonary hypertension

A Phase IIII study to assess the efficacy and safety of intravenous (IV) sildenafil when added to inhaled nitric oxide (iNO) for the treatment of newborns with persistent pulmonary hypertension (PPHN) did not meet its primary efficacy endpoint.

Sildenafil is marketed by US pharma giant Pfizer (NYSE: PFE) under the trade name Revatio in the pulmonary arterial hypertension indication, but is much better known as the erectile dysfunction drug Viagra.

Treatment with IV sildenafil when added to iNO did not result in a statistically significant reduction in treatment failure rate or time on iNO compared to treatment with iNO alone. Sildenafil is not indicated for the treatment of PPHN. The study was part of an EU Pediatric Investigational Plan (PIP).