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FDA Expands Labeling for Fast-Acting Erectile Dysfunction Drug, Stendra (Avanafil)

Treatment administered within 15 minutes of sexual activity

The FDA has approved a supplemental new drug application (sNDA) for Stendra (avanafil, Vivus, Inc./Auxilium Pharmaceuticals). Stendra is now the only FDA-approved erectile dysfunction (ED) medication indicated to be taken as early as approximately 15 minutes before sexual activity.

Avanafil is a phosphodiesterase type 5 (PDE5) inhibitor approved for the treatment of ED in men 18 years old or older. The treatment is available in multiple dosage strengths (50-mg, 100-mg, and 200-mg tablets) and may be taken with or without food and with moderate alcohol consumption (up to three drinks). In clinical studies, when compared with placebo, avanafil helped more men achieve an erection in as early as approximately 15 minutes that lasted long enough to successfully complete sexual intercourse.

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 was 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 (i.e., hypertension, atherosclerosis, or hyperlipidemia), diabetes, depression, alcohol use, smoking, pelvic/perineal surgery or trauma, neurologic disease, obesity, pelvic radiation, and Peyronie’s disease.

The sNDA for Stendra was based on results from a study designed to assess the efficacy of two dosage strengths of avanafil as early as approximately 15 minutes after dosing. In this investigation, 440 patients treated with avanafil 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 with placebo. The previously approved prescribing information recommended administration approximately 30 minutes before sexual activity.

Stendra should not be taken more than once per day.

Source: Auxilium Pharmaceuticals; September 18, 2014.

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