MOUNTAIN VIEW, Calif. — VIVUS Inc. has received approval from the Food and Drug Administration for Stendra tablets (avanafil), indicated for the treatment of erectile dysfunction (ED).
The company said Friday that the FDA clearance marks the first new prescription medication approved in nearly a decade for ED, which afflicts as many as 30 million men in the United States.
"Patients and treating physicians continue to report significant dissatisfaction with current treatments of ED," stated Peter Tam, president of VIVUS. "We believe that the PDE5 selectivity and absorption profile of Stendra make it an important new treatment option for many men with erectile dysfunction."
VIVUS said it’s in discussions with potential partners to commercialize Stendra, licensed from Mitsubishi Tanabe Pharma Corp., in the United States and in its territories in the rest of the world.
"Stendra is the first of a new generation of PDE5 inhibitors, and the approval marks an exciting new milestone for the millions of men suffering from erectile dysfunction who are in need of a new treatment option," commented Dr. Wayne Hellstrom, professor of urology and chief of andrology (male infertility and sexual dysfunction) at Tulane University School of Medicine in New Orleans.
