FDA approves STENDRA for ED
The FDA has approved a supplemental new drug application (sNDA) for Vivus’ STENDRA (avanafil). STENDRA now is the only FDA-approved erectile dysfunction (ED) medication indicated to be taken as early as approximately 15 minutes before sexual activity.
STENDRA is a prescription medication in a class of drugs known as phosphodiesterase type 5 (PDE5) inhibitors approved for the treatment of ED in men 18 years or older. STENDRA is available in multiple dosage strengths (50mg, 100mg and 200mg tablets) and may be taken with or without food and moderate alcohol consumption (up to three drinks). In clinical studies, when compared to placebo, STENDRA helped more men achieve an erection in as early as approximately 15 minutes that lasted long enough to successfully complete sexual intercourse.
"ED patients in my practice are looking for a safe and effective treatment option that also works fast," said Wayne JG Hellstrom, M.D., FACS, professor of urology at Tulane University School of Medicine in New Orleans and primary investigator for the clinical trial. "In my opinion, STENDRA can be an appropriate and important treatment option because the clinical trial demonstrated that it provides a rapid onset of action in many men in as early as approximately 15 minutes."
ED is the inability to attain or maintain a penile erection for sufficient sexual performance. Men may experience ED differently. Many men with ED experience one or more of the following: trouble achieving an erection; difficulty achieving an erection firm enough for penetration; or erections not lasting long enough to have successful intercourse.
In the Massachusetts Male Aging Study, it is estimated that 52% of men over 40 years of age experience some degree of ED. In addition to advanced age, recognized risk factors for erectile dysfunction include cardiovascular disease (hypertension, atherosclerosis and hyperlipidemia), diabetes, depression, alcohol use, smoking, pelvic/perineal surgery or trauma, neurologic disease, obesity, pelvic radiation and Peyronie's disease.
The sNDA filed by Vivus was based on results from Study TA-501 entitled, A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men with Erectile Dysfunction. The study was designed to assess the efficacy of two dosage strengths of STENDRA as early as approximately 15 minutes after dosing.
In the 440-patient study conducted at 30 sites in the U.S., patients treated with STENDRA had a significantly higher proportion of attempts that enabled an erection sufficient for successful sexual intercourse as early as approximately 15 minutes following administration compared to placebo. The previously approved prescribing information recommended administration approximately 30 minutes before sexual activity.