Pfizer Announces That Revatio (Sildenafil) Did Not Meet Primary Efficacy Endpoint for Newborns with PPHN

Persistent Pulmonary Hypertension (PPHN) in newborns is defined as the failure of the normal circulatory transition that occurs after birth.


Pfizer, which sells blockbuster drug Viagra for Erectile Dysfunction (ED) and Revatio for Pulmonary Arterial Hypertension (PAH), has announced that intravenous (IV) sildenafil added to inhaled Nitric Oxide for treating newborns with Persistent Pulmonary Hypertension (PPHN) did not meet its primary efficacy endpoint after considering the findings of Phase 3 Study to assess its safety and efficacy.

The pharmaceutical giant said, “Treatment with IV sildenafil, when added to inhaled Nitric Oxide, did not result in a statistically significant reduction in treatment failure rate or time on inhaled Nitric Oxide compared to treatment with inhaled Nitric Oxide alone.”

Sildenafil Citrate is not recommended for the treatment of PPHN.

This Phase 3 study was part of an EU Pediatric Investigational Plan (PIP).

The safety and adverse events observed in this study were comparable to the known safety and adverse events of Revatio in prior studies in children and adults with PAH taking Revatio.

The study found that most adverse events were of mild to moderate severity, which were consistent with the known pharmacology of sildenafil and other phosphodiesterase-5 (PDE5) inhibitors. The benefit-risk profile of Revatio remained favorable.

The European Commission first approved Revatio in October 2005 for the treatment of PAH in adult patients, which is classified as WHO functional class II and III to improve exercise capacity.

Revatio has been approved for the treatment of pediatric PAH in the EU and Japan.

PAHis characterized by high blood pressure in the lungs. In this condition, the heart has to work hard to pump blood into the lungs. Revatio improves the ability to exercise, slowing down worsening changes in your overall physical condition.