The Food and Drug Administration (FDA) announced that it had approved avanafil (Stendra), marketed by Vivus for the treatment of erectile dysfunction.

Erectile dysfunction, which is difficulty in obtaining or maintaining an erection, is estimated to affect an estimated 30 million men in the United States; it affects an estimated 52% of men between the ages of 40 and 70 and is treated with ompotence drugs like Stendra.

Stendra belongs to a class of drugs known as phosphodiesterase type 5 (PDE5) inhibitors, which are used to help increase blood flow to the penis.

The new drug is the fifth FDA-approved oral drug for erectile dysfunction. The others are tadalafil (Cialis; Eli Lily), vardenafil (Levitra; Staxyn, Bayer Healthcare Pharmaceuticals), and sildenafil (Viagra; Pfizer).

Vivius conducted clinical trials that included more than 1,200 men with erectile dysfunction to evaluate the effectiveness and safety of Stendra at all dosage strengths (50 mg, 100 mg, and 200 mg).

Significant improvement in erectile function was observed for all doses in Stendra treated patients compared to placebo. The pill is taken 30 minutes before engaging in sexual activity.

“This approval expands the available treatment options to men experiencing erectile dysfunction, and enables patients, in consultation with their doctor, to choose the most appropriate treatment for their needs,” noted Victoria Kusiak, MD, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research.

PDE5 inhibitors such as Stendra may rarely cause color vision changes.

In rare instances, men taking PDE5 inhibitors have reported a sudden loss of vision in one or both eyes. Sudden loss or decrease in hearing has also been reported in patients taking PDE5 inhibitors. Patients who experience a sudden loss of vision or hearing should stop taking PDE5 inhibitors, including Stendra, and call a physician right away.

The most common side effects reported in more than 25 of patients in the clinical studies of Stendra include headache, redness of the face and other areas (flushing), nasal congestion, common cold-like symptoms (nasopharyngitis), and back pain.

In rare cases, patients taking Stendra and other PDE5 inhibitors may get an erection lasting four hours or longer that will not go away (priapism). If this happens, patients should seek immediate medical attention.

The prevalence of erectile dysfunction increases with age and can be caused by a variety of factors, including medications (anti-hypertensives, histamine receptor antagonists); lifestyle (tobacco, alcohol use); diseases (diabetes, cardiovascular conditions, prostate cancer); and spinal cord injuries. Left untreated, the condition can negatively impact relationships and self-esteem, causing feelings of embarrassment and guilt.

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