Peter Tam, president of the biopharmaceutical company Vivus, said the approval is the first for nearly a decade to help treat the 30 million U.S. men with erectile dysfunction.
"Patients and treating physicians continue to report significant dissatisfaction with current treatments of erectile dysfunction," Tam said in a statement. "We believe that the PDE5 selectivity and absorption profile of Stendra make it an important new treatment option for many men with erectile dysfunction."
More than 1,200 men with erectile dysfunction participated in clinical studies evaluating the efficacy and safety of Stendra, and significant improvement in erectile function was observed for all doses -- in 50milligrams, 100mg and 200mg -- compared to placebo.
It is recommended that Stendra should be taken approximately 30 minutes before sexual activity and should not be taken more than once per day.
Erectile dysfunction affects an estimated 52 percent of men between the ages of 40 and 70, Tam said.
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