Health care major Pfizer Inc. (PFE) said Friday that the U.S. Food and Drug Administration or FDA approved an intravenous formulation of Revatio or sildenafil for continued treatment of patients with pulmonary arterial hypertension, who are unable to take oral medication.
Revatio is indicated for the treatment of adult patients with pulmonary arterial hypertension to improve exercise ability and delay clinical worsening. The disease, rare, incurable and progressive, is characterized by continuous high blood pressure in the pulmonary arteries, often leading to heart failure and premature death. Statistics show that the disease affects an estimated 100 thousand men and women worldwide.
Revatio is the only FDA-approved phosphodiesterase-5 or PDE5 inhibitor available in both tablet and intravenous formulations.
Pfizer intends to supply Revatio injection in a single-use vial, with the recommended dose of 10 mg corresponding to 12.5 ml administered as an intravenous bolus injection three times a day.
Cara Cassino, vice president of pulmonary vascular disease, clinical development and medical affairs, Pfizer, commented, "The approval of Revatio Injection is a clear demonstration of Pfizer's commitment to developing treatments addressing the unmet needs of patients with pulmonary arterial hypertension."
New York based Pfizer indicated that Revatio contains the same medicine as Viagra or sildenafil, which is used to treat erectile dysfunction and has warned that Revatio should not be taken with Viagra or other PDE5 inhibitors.
The company also noted that the most common side effects of Revatio are nosebleeds, headache, upset stomach, flushing, and trouble sleeping.
PFE is trading at $18.23, up $0.12 or 0.66%, on a volume of about 8.15 million shares.
by RTT Staff Writer
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