NEW YORK , December 3, 2004 -- Pfizer Inc today announced it has submitted regulatory filings in the United States and Europe for RevatioTM (sildenafil citrate) as a treatment for pulmonary arterial hypertension (PAH), a rare, aggressive and life-shortening vascular disease. Sildenafil is the active ingredient in Viagra®, Pfizer’s erectile dysfunction medication used by more than 23 million men worldwide.
The company filed a New Drug Application for Revatio with the U.S. Food and Drug Administration and submitted its Revatio dossier to regulatory authorities in the Netherlands and Spain , the rapporteur and co-rapporteur sponsors, and the European Medicines Agency (EMEA).
“The regulatory filings for sildenafil usage in PAH demonstrate Pfizer’s commitment to address unmet medical conditions by exploring new uses for our existing medicines, together with our significant efforts to discover and develop new compounds,” said Joseph Feczko, M.D., president of Worldwide Development. “PAH is a condition for which new treatment options are desperately needed.”
PAH, often referred to as high blood pressure of the lungs, affects approximately 100,000 people in North America and Europe . Those afflicted are usually women between the ages of 21 and 50. PAH can occur without obvious causes or be the secondary result of other diseases that impede blood flow to the lungs, including connective tissue diseases (such as scleroderma), congenital heart disease, exposure to substances including appetite suppressants or infectious agents such as HIV. Symptoms of the disease include fatigue, shortness of breath on exertion, chest pain, and dizziness. Left untreated, median survival time after diagnosis can be as short as three years.
Clinical studies conducted throughout the world have shown sildenafil 20 mg taken three times daily to be effective in treating PAH. Patients treated with sildenafil had improved physical functioning as demonstrated by increased walking distance over a six-minute time interval. Patients on sildenafil also had both a reduction in blood pressure in arteries of the lungs and an increase in cardiac (heart) output which is critical in treatments of this disease.
The most commonly reported adverse events in PAH patients were headaches, flushing and dyspepsia. The overall side effect profile was similar to what has been observed with Viagra.
Revatio will be manufactured and marketed in a different dosage, color and shape than Viagra.
Viagra® (sildenafil citrate) is a prescription medication only indicated for the treatment of ED. Viagra is available only from health care providers and should always be used in accordance with its approved labeling. Viagra is contraindicated in patients who use nitrates in any form at any time.