sábado, 1 de dezembro de 2012

Viagra spray lançamento nos EUA. Aqui já temos no Grupo de Andrologia.

A Viagra Spray On Its Way… Novadel Prepares Oral Erectile Dysfunction Treatment Duromist

By Brian Bujdos
Novadel has announced positive study results for Duromist, the "Viagra spray" that it is developing as an oral treatment for erectile dysfunction.Promising new results from a preliminary study indicate that a “Viagra spray” may be on the way.  Novadel, a New Jersey-based pharmaceutical company that develops oral spray formulations for a broad range of marketed drugs, is now working with the U.S. Food & Drug Administration (FDA) to proceed on a pathway toward a successful New Drug Application (NDA).
Several clinical trials must still take place for the prescription-only “Viagra spray,” dubbed Duromist by Novadel, and that can take a few years. However the results from the first study of 24 healthy men were extremely encouraging.
Novadel’s novel concept for a new erectile dysfunction (ED) medication comes just four months after GlaxoSmithKline (GSK) gained FDA approval for a new form of its ED drug Levitra (called Staxyn). GSK announced in June that Staxyn, which dissolves on the tongue, is expected to be available by the end of 2010. Currently, there are only three FDA-approved ED medications on the market (Viagra, Cialis and Levitra).
It could be expected that tongue-dissolvable Levitra and Novadel’s Duromist would be the fastest-acting versions of any ED pill. However, GSK’s prescribing information for Staxyn did not indicate quicker absorption into the body.
Duromist is a "Viagra spray" that is being developed by Novadel. It would be a prescription medication for erectile dysfunction (ED) if approved by the FDA.Novadel blatantly states, however, that Duromist and its other spray medications are absorbed through the transmucosal route (within the mouth), which provides “potential for faster absorption of drugs into the bloodstream leading to quicker onset of therapeutic effects and possibly reduced first-pass liver metabolism, which may result in lower doses. Oral sprays eliminate the requirement for water or the need to swallow, potentially improving patient convenience and adherence.”
Although the preliminary study for Duromist was a small one, the product was deemed to have an excellent safety profile. In fact, none of the 24 participating men displayed evidence of oral irritation or other adverse events after receiving three doses of Duromist (one spray/dose = 10 milligrams). Novadel also reported that vital signs were within normal range and there were no episodes of orthostatic hypotension observed in any of the men during their four treatment periods. And lastly, the men experienced no changes with their electrocardiograms in any of the four treatment periods.
Without getting too technical, the researchers concluded that 20 mgm, or two sprays, of Duromist is bioequivalent to the 25 mg Viagra tablet with respect to systemic exposure (AUC0-inf). Viagra is available in both 100 mg and 50 mg tablets, and many men split the tablets in order to utilize the lowest effective dose.
“This initial clinical study provides NovaDel with a solid foundation for our future clinical development efforts (with Duromist),” said Mr. Steven B. Ratoff, NovaDel’s Chairman of the Board, President & Chief Executive Officer.
The ED drug market will continue to evolve over the next few years as these new products come to market. However, the biggest change will take place when Pfizer loses its Viagra patent in March of 2012. The cost of prescription ED medications will surely plummet at that time, as FDA-approved generic Viagra (sildenafil citrate) will become readily available.
Read more about what might happen when the Viagra patent expires.

Read more: http://www.accessrx.com/blog/current-health-news/viagra-spray-duromist-novadel-ed-erectile-dysfunction-a1018/#ixzz2DqLoz9rt
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