FDA approves VIVUS’ STENDRA for treatment of erectile dysfunction
Published on April 30, 2012 at 12:41 AM
VIVUS, Inc. (NASDAQ: VVUS) today announced that the U.S. Food and Drug Administration (FDA) has approved STENDRA (avanafil) tablets for the treatment of erectile dysfunction (ED), marking the first new prescription agent approved in nearly a decade for the condition that afflicts as many as 30 million men in the U.S.
"Patients and treating physicians continue to report significant dissatisfaction with current treatments of ED," said Peter Tam, president, 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."
More than 1,200 men with ED participated in clinical studies evaluating the efficacy and safety of STENDRA. STENDRA at all doses tested (50mg, 100mg and 200mg) met all primary efficacy endpoints. Significant improvement in erectile function was observed for all doses in STENDRA-treated patients compared to placebo.
It is recommended that STENDRA should be taken approximately 30 minutes before sexual activity. STENDRA should not be taken more than once per day. For more information about STENDRA, please visit www.Stendra.com.
"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," said Dr. Wayne Hellstrom, Professor of Urology and Chief of Andrology (male infertility and sexual dysfunction) at Tulane University School of Medicine in New Orleans.