ePillz.com - Final Trials of Avanafil Are Initiated

Final Trials of Avanafil Are Initiated

December 12, 2008

-Vivus, Inc-

On December 12, 2008 the pharmaceutical company Vivus, Inc announced about the start of the final phase 3 trials of avanafil – the company's investigational product, which is designed to join the line of PDE-5 inhibitors, such as Viagra, Levitra and Cialis, currently available on the market for the treatment of male erectile dysfunction (ED) or impotence.

Avanfil belongs to the group of medications, known as PDE-5 inhibitors, which are the mainstream of ED treatment nowadays. In year 2007 pharmaceutical companies sold such medications for the amount of 3 billion dollars in total and the market still continues to grow. Vivus, Inc confirms that their new medication possesses certain advantages over the existing PDE-5 inhibitors. For example, avanafil is said to work faster (the erection may be achieved in 30 minutes after taking a pill), and due to very short half-life it should be safer than any other of the existing PDE-5 inhibitors.

The Phase 3 trials, which are in fact the final set of clinical studies necessary for submitting an application for new drug approval by the U.S. Food and Drug Administration, will include four different trials, focused on additional studying of avanafil properties. The initiation of the first trial has already been announced by Vivus, Inc.

This study, called REVIVE (TA-301), aims at providing valid evidences of the efficacy and safety of avanafil in men with the history of erectile dysfunction. The program will enroll over 600 patients at about 40 sites in the USA. The participants will undergo 4-week run-in period, followed by 12-week treatment period, during which men with ED will be given either placebo pill or avanafil (50 mg, 100 mg or 200 mg doses).

At the end of the first Phase 3 trial all the participants will be observed to measure the improvements of their condition, based on the Sexual Encounter Profile and the International Index of Erectile Function score (IIEF).

In addition to studying efficacy and safety of avanafil, the manufacturers also plan to run separate studies to evaluate the use of new medication in men with ED and diabetes, and those after post-radical prostatectomy. Additionally, there is also one safety study planned for the beginning of 2009. The company expects to receive the first results of the Phase 3 trial by the end of 2009.

As it was stated by Leland Wilson, president and chief executive officer of VIVUS, "Initiation of the phase 3 studies of avanafil is an important corporate milestone for VIVUS". Taking into account that the initiated trials are the final stage of drug clinical evaluation before official approval, avanafil is likely to become the next ED medication after sildenafil (Viagra), vardenafil (Levitra) and tadalafil (Cialis).

About the Avanafil Phase 2 trials results

The previous trials on avanafil provided very promising results. The medication produced erections hard enough for vaginal penetration in 76, 79, 80 and 84 % of sexual attempts on the 50, 100, 200 and 300 mg doses, respectively. Besides, avanafil was also shown to be able to help men maintain erection for the period of time necessary for successful intercourse. The company also informed in its press-release that avanafil was generally well-tolerated, with headache as the most common adverse reaction.

Nick

External resources
http://phx.corporate-ir.net/staging/phoenix.zhtml?c=79161&p=irol-newsArticle&...
http://www.medicalnewstoday.com/articles/133044.php
http://www.epillz.com/info/avanafil-trials.html