Pfizer’s gamble on a new lease on life for aging sildenafil franchise fizzles in PhIII
Pfizer took a Phase III shot at repurposing its old drug sildenafil as a new combination therapy for persistent pulmonary hypertension in infants. And failed.
Approved in pill form for erectile dysfunction (Viagra) and PAH (Revatio), researchers took an IV formulation added to inhaled nitric oxide into a pivotal trial in PPHN for newborns. The study proved that it was no better at reducing treatment failure or time on nitric oxide than nitric oxide alone.
Pulmonary hypertension involves the constriction of pulmonary arteries, which forces the heart to work harder to pump blood to the lungs. It’s called persistent pulmonary hypertension in newborns, a rare and sometimes fatal condition that decreases the flow of oxygen as the normal changeup in blood flow at birth fails to occur.
Revatio was approved for PAH 14 years ago and has been widely distributed around the globe. That came 7 years after the same active ingredient was approved as Viagra, now 21 years old in marketing years. A company called Novitium obtained a generic approval for PAH just days ago.
Social image: Kristoffer Tripplaar, AP Images