November, 17-20 - Vivus, Inc. -

The results of the five key trials of a new impotence pill – avanafil, were presented at the meeting of Sexual Medicine Society of North America, which took place on November 17-20 in New York City.

Traditionally, this meeting is one of the key events for doctors and healthcare providers, specializing on sexual health issues, to discuss the newest approaches and investigational drugs for treating different sexual disorders, such as male erectile dysfunction, female sexual disorder etc.

Avanafil, developed by Vivus, Inc. - California based company, is a potentially new upcoming rival to Viagra, Levitra and Cialis – the only approved by Food and Drug Administration oral drugs to treat erectile dysfunction (ED) for the time being. Though Avanafil is not yet approved officially, the available results of Phase 2 studies, concentrated on five aspects (enzyme selectivity, pharmacokinetics, hemodynamic effects of co-administration of avanafil with nitrates, human safety and efficiency) added much confidence to the developers of this drug.

The most interesting facts from avanafil presentation are the following:

1) Avanafil, being PDE-5 inhibitor as well as Viagra, Levitra and Cialis, has better selectivity in affecting PDE-5 enzymes. That means that avanafil works more precisely in that very substance in male penis, which is considered to be the main cause of ED on the level of chemical reactions.

2) Avanafil demonstrates very promising pharmacokinetics trial results – it reaches its maximum concentration in blood in 35 minutes and completely disappears in about 1.5 hours. Thus, avanafil can work as quickly as 35 minutes after the administration. Short life-period of avanafil promises to decrease the number of side effects, associated with this drug, in comparison to its analogues.

3) Clinical studies showed that avanafil, when used together with nitrates, like nitroglycerin, caused smaller changes in blood pressure and heart rate. It is known that patients, using Viagra, Levitra or Cialis to treat ED, should avoid using nitrate medications, because of the increased risk of cardio-vascular diseases.

The results of the recent trials allow avanafil developers to start preparations for Phase 3 trials, necessary for obtaining FDA approval. According to the prognosis, the marketing of avanafil can start in 2007, provided that all the trial results will be positive and FDA will approve this drug for use.

About Vivus, Inc. Vivus, Inc. (www.vivus.com) is a company, researching and developing new products to restore and improve sexual function of men and women. For the time being Vivus is marketing alprostadil (MUSE) for ED treating. At the same time, the company is working on three projects: Alista, Evamist and Testosterone MDTS for treating female sexual disorders, such as arousal disorder, menopausal symptoms and decreased sexual desire.

Nick

---

External resources
http://ir.vivus.com/phoenix.zhtml?c=79161&p=irol-newsArticle&ID=784250&highli...
http://pharmalicensing.com/licensing/displicopp/3971
http://www.vivus.com/main.taf?p=3,3,2,1
http://www.4woman.gov/news/english/529236.htm

(C) ePillz.com, All rights reserved.
This material may not be published, broadcast, rewritten, or redistributed in any form.

Your Feedback for This Article

Nickname: Input code the below: