Ny (Reuters Health) Apr 05 - An investigational phosphodiesterase type 5 (PDE5) inhibitor, avanafil, was an effective and well tolerated treatment for erectile dysfunction (ED) in a randomized controlled trial in Korea.
"Considering these data, avanafil can provide another reliable treatment option for ED patients," the authors conclude within a report online March 27 in BJU International.
Dr. Jong Kwan Park, with the Medical School of Chonbuk National University in Jeonju, and colleagues note that avanafil selectively acts on PDE5 and is rapidly absorbed, reaching peak blood levels in 20 to half an hour.
In this phase III trial, 200 men with ED were randomized to take 100 mg or 200 mg avanafil or placebo as needed for a 12 week period. At the conclusion of your study, mean adjustments to the erections domain (EFD) of your International Index of Erections were 8.5 to the 100 mg group and 8.8 for any 200 mg Group -- significantly more than 3.5 within the placebo group (p<0.001), the investigators report.
"The proportion of patients achieving normal EFD scores has been popular to judge the efficacy of PDE5 inhibitors," they point out. Within this study, after 12 weeks 45.6% and 39.39% of patients achieved normal EFD scores while in the 100-mg and 200-mg avanafil groups, respectively, in comparison with 16.7% in the placebo group.
Most negative effects were mild and transient, the c's found. The most typical was flushing, occurring in 11.4% and 13.0% of these two avanafil groups weighed against 2.9% of the placebo group.
Dr. Park and colleagues conclude, "The initial clinical properties (higher selectivity and faster onset) of avanafil will provide a welcome addition to current ED management."
Avanafil is approved in Korea, where it is marketed by JW Pharmaceutical Co., the sponsor with the current trial. Within the U.S., avanafil is manufactured by Vivus, Inc. Earlier this September, the U.S. Food and Drug Administration (FDA) accepted their new drug application for avanafil; the point date to the FDA to complete its review is April 29, 2012. The ecu Medicines Agency (EMA) in addition has accepted a Marketing Authorization Application for avanafil from Vivus.
Avanafil may be the new gossip while in the Ed drug market that's experiencing investigation and experimentation during men with long history of erectile dysfunction. Avanafil starts getting work done in less than a quarter-hour and how it can cause low unwanted effects really is making news everyday. This drug influences testing process and is also attracting many customers. In 2010 the effects with the phase 3 test were out wit maximum success rates. Comparing to Viagra, Cialis and Levitra, Avanafil stays while in the system for the not much some time and because of this , this drug can be a favorite ED solution. Though it works exactly like Viagra, Cialis and Levitra, it functions by inhibiting an enzyme protease from blocking the arteries and inside the genitals and give the person a way to an excellent sexual activity.
This blockage develops resulting from a protein that will not allow expansion of blood inside the penis. So, after a intercourse your penis doesn't achieve erection. Without sexual stimulation, no drug for your therapy for impotence can be effective. Here identical case only occurs in case of Avanafil. Sexual stimulation is a must for erection to take place after ingestion of your drug. You can find low sde effect as well as ability of Avanafil to attain its full plasma levels quickly just in 15 minutes is the reason why it a significant hit from the Google internet search engine.
Once the drug was ready, Vivus started its first test with 295 men who had different levels of erection problems. Is really a popular test effects were positive, the drug needed to go through additional tests. Now Avanafil is going through further tests for guys with diabetes and also other internal disorders. This was followed by another test with 646 men who stood a prominent and longer history of male impotence. 80% of the men had erections after half-hour of taking drug. The men ingested the dose degree of 200 mg. A comparable timing is achieved from Levitra nevertheless it has more negative effects than Avanafil.
In January 11th, 2010 Avanafil was tested to test how quickly it may possibly work and also the decreased a serious amounts of some time recorded was a quarter-hour to realize erection in many. The medial side effects from your drug was mild to moderate and was listed to become slight facial flushing, minor headache and nasal congestion. Avanafil successfully met the FDA's requirements dependant upon the Sexual Encounter Profile score. The scores showed a gradual rise in the development in sexual functioning. No other drug indicates so much efficacy and rate of success. No drug has worked as soon as Avanafil design it remains in blood for bit of time, you can find lesser uncomfortable side effects from this drug. In the event the phase 3 tests still impress, then Avanafil will certainly function as drug for the future. Patients are likely to modify with ED drugs if Avanafil will cause adverse uncomfortable side effects.