FDA OKs ED Drug Avanafil for Use 15 Minutes Before Sex
Troy Brown, RN
September 18, 2014
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Avanafil (Stendra, Vivus and Auxilium Pharmaceuticals) has been approved by the US Food and Drug Administration (FDA) to be taken by patients with erectile dysfunction (ED) as early as about 15 minutes before sexual activity, according to a statement from both companies.
The FDA approved avanafil for use 30 minutes before sexual activity in patients with ED in April 2012. It is now the only ED treatment approved by the FDA for use as early as 15 minutes before sex.
More than half (52%) of men between the ages of 40 and 70 years have ED, and its prevalence increases with age. ED has a variety of causes, including medications (antihypertensives, histamine receptor antagonists), tobacco and alcohol use, diabetes, cardiovascular conditions, prostate cancer, prostatectomy, and spinal cord injuries.
Avanafil is a phosphodiesterase type 5 inhibitor that is approved for use by men aged 18 years or older. It is available in 50-, 100-, and 200-mg tablets and can be taken with or without food. It may also be taken after consumption of up to 3 alcoholic beverages.
The FDA approved the supplemental new drug application after consideration of results from a randomized, double-blind, placebo-controlled clinical trial that assessed the drug's efficacy in 440 patients at 30 sites in the United States. The study included patients with and without diabetes.
Patients who took avanafil reported a significantly higher proportion of attempts that resulted in an erection adequate for successful sexual intercourse as soon as 10 minutes after taking the 200-mg dose and 12 minutes taking the 100-mg dose compared with placebo.
"ED patients in my practice are looking for a safe and effective treatment option that also works fast," Wayne J.G. Hellstrom, MD, professor of urology at Tulane University School of Medicine in New Orleans, Louisiana, and primary investigator for the clinical trial, said in the statement. "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."
The most frequently reported adverse effects were headache and nasal congestion. No drug-related serious adverse events were reported.
Patients who take nitrates should not use avanafil.
More information about avanafil may be found at the FDA's Web site.
I hope this gives you some information that you can use fellas, this is from medscape,
