Avanafil - New Erectile Dysfunction Drug

     Avanafil is a trial medication produced by Vivus Inc that is currently be studied for erectile dysfunction. Avanafil is what is known as a PDE5 (phosphodiesterase type 5) inhibitor. There is a protein in the body that prevents blood vessels from expanding. Avanafil in essence prevents or blocks this protein so blood vessels can expand. Thus allowing blood to enter the penis and become erect during times of sexual excitement. Its premises is similar to that of vardenafil, sildenafil and tadalafil which are currently on the market as the trademarked names Levitra®, Viagra® and Cialis® respectively. Because of Avanafil's nature in how it works, some other potential uses for Avanafil (but not necessarily being studied as such, nor being prescribed as such) are urinary tract problems, types of hypertension, stroke prevention, improved female sexual function, blood clots in the circulatory system, Alzheimers disease and some others.
     Studies show that Erectile Dysfunction can affect men more so as they grow older. Up to 40% of men will experience it at age 40 and 65% of men over the age of 65. Another statistic is that it affects 1 in 10 men worldwide. As many as 15-30 million men (depending on how exactly it is defined) in the United States suffer from Erectile Dysfunction. With such numbers at stake there is a desire to find help in this area. Currently there are medical treatments such as the medications mentioned above, the advantage that Avanafil has going for it is the time it takes for the drug to start working and its reported low side effects. Times seem to vary depending on what reports you read but Cialis ® is reported to work in as little as 30 minutes but most take it somewhere between 30minutes and 12 hours before because it takes over 30 minutes to reach full plasma levels. One is to take Viagra® approximately 1 hour before and Levitra® about one hour before. All have their benefits and negatives. But Avanafil is reported to start working in 30 minutes or less. It claims to be quicker than 'the others'. This may be the key to Avanafil in a market already having effective ED medications. Avanafil also reportedly stays in the blood less time which could potentially lead to fewer side effects than other treatments. Some of the side effects in phase 3 trials where a low but consisted of headache, skin flushing, nasal congestion but no visual imparities like that seen in sildenafil. Where Sildenafil (Sildenafil Citrate) or commonly known as Viagra® may have an advantage is when the generic will become available in 2012 due to the patent for sildenafil citrate expiring that year. This would make the generic version of Viagra® a most likely cheaper alternative.

• FDA filing for Avanafil looks to be in late 2010 or early 2011
• Market Launch expected in early 2012.

November 18th 2009
      In phase 3 studies, over 600 males suffering from different degrees of Erectile Dysfunction took part. The results where very promising. In the test, different amounts where administered including a placebo. Of the 200mg dose group, approximately 80% of the men had erections that where good enough to have intercourse. It was also found to work in 30 minutes or less and work between 30 minutes and 6 hours. During the studies all of the FDA endpoints where obtained and as seen above, low side effects reported. Some say lower side effects than current drug treatments.

January 11th 2010
     News out today from Vivus Inc said in a late stage clinical trial that most men who took part in a study where able to have sex within 15 minutes after taking Avanafil. The study showed that 2/3 of the men who took the smaller dose of 50mg could have intercourse within 15 minutes. The study also showed that number increased to 69% for those who were given a 100mg dose and 72% for those who were given a 200mg dose.

May 28th, 2010
     Vivus, Inc. Phase 3 information will be presented on June 1st, 2010 at the American Urological Association's 2010 Annual Meeting in San Francisco, California. It will include results from its latest phase 3 study with 646 men with erectile dysfunction. Stay Tuned June 1st.

June 1st, 2010
     Today the results from the American Urological Association's meeting where reported. Vivus states that successful erections for intercourse was reported with almost 80% of patients taking the 200mg dose. Also that Avanafil works in as short as 15 minutes and can last beyond 6 hours. It is also well tolerated with low rates of typical PDE5 inhibitor side effects. It was stated that they hope that Avanafil can help those many men who become frustrated with other treatments due to the time they take to work and their side effects. Vivus feels that Avanafil is very impressive with its fast onset time and overall results. Vivus Inc expects to submit a filing for Avanafil to the FDA for a New Drug Application (NDA) in the first half of 2011.

June 8th, 2010
     Recent testing involving 390 men with Erectile Dysfunction and diabetes showed similar positive results as men with just erectile dysfunction. It is rumored that perhaps Vivus is looking to target men with diabetes and ED. Some statistics show that men with diabetes have higher numbers of ED than men without.

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