New impotence medication submitted for FDA approval
A new medication to treat erectile dysfunction has been submitted to the Food and Drug Administration in the United States.
The medication, avanafil, is manufactured by VIVUS, Inc. and has already been tested by a series of clinical trials which are said to have proved its safety and efficacy. The New Drug Application (NDA) was submitted in the hope that the medication will become a profitable alternative to the leading impotence medications that are currently available; Viagra, Cialis and Levitra.
The clinical trials, which involved over 1,350 patients, have been completed up to phase III, with results demonstrating that the medication showed results in as little as fifteen minutes and was “well tolerated” by the patients. The process of approval from the FDA can take several months, so it may be some time before a decision is reached.
Like its competitors, avanafil is a PDE-5 inhibitor, meaning it treats erectile dysfunction by preventing the PDE-5 enzyme from breaking down cyclic GMP too early. If it is approved, VIVUS will be entering an extremely lucrative market, which is worth an estimated $4 billion worldwide. Viagra was the first medication to be approved for impotence treatment in 1998 and in the years since then Cialis and Levitra have also become very popular.
The emergence of a new product could have a real impact on the impotence treatment industry, especially as the patent on Viagra is due to expire in 2012. As the market becomes increasingly competitive, the pharmaceutical companies are developing more innovative products, such as Levitra Orodispersible tablets, in an attempt to stand out in the field.