Avanafil-information.com
 
Your informational guide to Avanafil
Avanafil Has Been Approved by the FDA for erectile dysfunction. It has the trademark name Stendra®

     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.
   



















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.

December 6th, 2010
     Positive results were reported today in a press release from Vivus regarding their "TA-314" phase 3 clinical testing of Avanafil. All of its primary endpoints where satisfied in these studies. These were measured by the Sexual Encounter Profile and International Index of Erectile Function. The studies showed that for men suffering from erectile dysfunction 80% were able to erections good enough for intercourse within the first 15 minutes after taking Avanafil. The studies also showed a very low discontinue rate of only 2.8%. Side effects common with this study where headaches (5.6%) skin flushing (3.5%) inflamed nasal passages (3.4%) and nasal congestion(2.1%) Vivus plans to complete the NDA (New Drug Application) that is submitted to the FDA in the 2nd quarter of 2011.

January 12th, 2011
     CEO Leland Wilson said that Avanafil helped 80% of men have sex within 15 minutes of taking it and can work upto 6 hours later. Another positive point with this medication is that because of it metabolizes rapidly, if desired, someone could safely take it once in the morning and another time in the evening.

May 17th, 2011
     Results from a phase 3 clinical trial on Avanafil where presented today at the 2011 Annual Meeting of the American Urological Association in Washington, D.C. While the results had previously been reported, this marks the first time these results where reported at a major medical meeting.
The highlights included for Avanafil

-provided erections significant enough for intercourse in 80% of test patients.

-successful intercourse was achieved as quickly as 15 minutes.

-This medication is well tolerated with less than 3% discontinuing it due to adverse side effects and no drug related serious adverse events reported.

-The most common side effects where headache (5.6%), skin flushing (3.5%)  nasopharyngitis (3.4%) and nasal congestion (2.1%)

May 25th, 2011
     Today positive news was released from a phase 3, clinical trial for men having had a prostatectomy (surgical removal of the prostate gland). The study met all endpoints in the almost 300 men taking part in the study (TA-303) according to the Sexual Encounter Profile both SEP2 and SEP3. The average age of the patients was 58 years old and 19 months past their prostatectomy as well all where diagnosed with severe ED. Successful intercourse was achieved for many within 15 minutes after the administration of Avanafil. Side effects where reported low and quit tolerable. The main side effects where headache, skin flushing and inflammation of the nasal passages. Patients who have had their prostate removed often have significant problems with Erectile Dysfunction, if Avanafil is approved, it could prove to be an attractive option for these men. The results will be presented at a Cancer Survivorship Symposium in Washington DC on June 17th 2011.

June 30th, 2011
     News out today that Vivus has filed Avanafil with the FDA. Under most circumstances it takes around 10 months for a complete review. It will most likely be in late April 2012 when the FDA decides on whether to approve Avanafil.

Sept 1st, 2011
     It was announced today that the FDA had accepted the new drug application (NDA) for Avanafil for the treatment of erectile dysfunction. A tentative date for when it will have a completed review is April 29th, 2012.

January 17th, 2012
     Vivus announced today that the results from their REVIVE clinical studies where published in The Journal of Sexual Medicine. For patients taking 50,100, and 200mg doses they where able to achieve intercourse within 15 minutes 64%, 67% and 71% of the time respectively. Patients who discontinued the testing due to adverse events where 1.9%, 3.1%, 2.5% respectively and a discontinue rate of 3.1% for the placebo group. This was verses a placebo rate of 27%. This shows a superior comparison to the placebo for all primary endpoints.

March 26th, 2012
     The European Medicines Agency (EMA) has accepted Vivus Inc's Marketing Authorization Application (MAA) for avanafil. This comes after the successful conclusion of a phase 3 clinical testing program which involved over 1350 patients. Three dosages where used in the study, 50mg, 100mg and 200mg. In the 200mg group, 77% of men taking avanafil had effective erections often within 15 minutes. This compares to the placebo group where only 54% where able. Actual successful intercourse was attained in 57% compared to the placebo group number of 27%.

April 27th, 2012
     The US Food and Drug Administration has approved Avanafil. It will be sold under the name Stendra®























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Avanafil is the generic name for a compound produced by Vivus Inc. It is currently be studied for erectile dysfunction.

(S)-2-(2-Hydroxymethyl-1-pyrrolidinyl)-4-(3-chloro-4-methoxybenzylamino)-5-[(2-pyrimidinylmethyl)carbamoyl]pyrimidine;4-[(3-Chloro-4-methoxybenzyl)amino]-2-[2-(hydroxymethyl)-1-pyrrolidinyl]-N-(2-pyrimidinylmethyl)-5-pyrimidinecarboxamide;Avanafil
© 2012
Chemical Makeup of Avanafil