Unlicensed herbal remedies for erectile dysfunction, available over the internet, could present serious health risks according to recent test results received by the MHRA. The MHRA received advice from the Federal Agency for Medicines and Health Products in Belgium as well as the Food and Drug Administration (FDA) in the USA on 'Africa Black Ant', 'Rock Hard Weekend', 'Pandora' and 'The Best'. These unlicensed products were found to contain the Prescription Only Medicine (POM) sildenafil, which should only be used when prescribed by a doctor and could cause potentially life-threatening high blood pressure. The products have been marketed over the internet as a 'herbal supplement'. However, consumption of sildenafil in unknown or uncontrolled quantities could be extremely dangerous and cause serious adverse reactions such as heart attacks and strokes.
VIVUS, Inc. (NASDAQ: VVUS) announced that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of avanafil, its investigational drug for the treatment of erectile dysfunction (ED). The NDA submission follows the successful completion of an extensive phase 3 program for avanafil, which included over 1, 350 patients, where avanafil was shown to be well tolerated and effective in treating men with ED. "This NDA filing is yet another major milestone for VIVUS and the avanafil program. The efficacy was consistent across all patient groups, with success observed in some patients in as early as 15 minutes after dosing. The drug was well tolerated and had a low dropout rate in all of the clinical trials. If approved, avanafil could be an attractive treatment alternative for the 30 million men in the United States who suffer from ED, " stated Leland F.
A recent study has revealed erectile dysfunction can be linked to gum disease. The research1, carried out on 70 male subjects, showed a correlation between gum disease and the ability to achieve an erection. The data indicates that as the severity of erectile dysfunction increased, so did the prevalence of chronic periodontitis (gum disease). Overall, more than four out of five men (81.8 per cent) with severe erectile dysfunction had gum disease. In comparison, in cases of mild erectile dysfunction, the incidence of gum disease was less than two in five men. According to the National Institutes of Health2, erectile dysfunction is defined as the inability to attain and or maintain an erection sufficient for satisfactory sexual performance. It is a condition that affects one in 10 men worldwide, and is more commonly experienced after the age of 403.
Increasing Bisphenol-A levels in urine are associated with worsening male sexual function, according to a Kaiser Permanente study appearing online in the Journal of Andrology. Increasing urine BPA level is associated with decreased sexual desire, more difficulty having an erection, lower ejaculation strength and lower level of overall satisfaction with sex life, researchers said. The five-year study examined 427 workers in factories in China, comparing workers in BPA manufacturing facilities with a control group of workers in factories where no BPA was present. BPA is an ingredient in manufacturing polycarbonate plastic and epoxy resins and is now contained in a wide variety of consumer products from baby bottles, plastic containers, and the resin lining of cans for food and beverages, to dental sealants.
Phase 3 Data On VIVUS' Avanafil For Erectile Dysfunction To Be Featured At The AUA 2010 Annual Meeting
VIVUS, Inc. (Nasdaq: VVUS) announced that phase 3 data on avanafil, a next generation oral phosphodiesterase type 5 (PDE5) inhibitor therapy being investigated for the treatment of erectile dysfunction (ED), will be presented next Tuesday at the American Urological Association (AUA) 2010 Annual Meeting in San Francisco, California. Irwin Goldstein, M.D., clinical professor of surgery at the University of California, San Diego, and director of sexual medicine at Alvarado Hospital in San Diego, will deliver an oral presentation as part of the Late-Breaking Science Forum session on Tuesday, June 1 entitled: "Avanafil for the Treatment of Erectile Dysfunction: Results of a Phase 3, Multi-Center, Randomized, Double Blind, Placebo-Controlled Clinical Trial." Dr Goldstein's presentation will include the results from the REVIVE (TA-301) study a randomized, double-blind, placebo-controlled phase 3 study of avanafil in 646 men with a history of generalized ED.