ePillz.com - Emerging Impotence Medications

Emerging Impotence Medications

November 16, 2007

- International Journal of Impotence Research –

- Dong-A Pharm –

- Vivus –

- Surface Logix –

For the time being there are three medications officially approved by the US Food and Drug Administration (FDA) for the treatment of erectile dysfunction (ED) in men. Though Viagra, Levitra and Cialis are extremely effective and safe, different pharmaceutical companies do not stop researching new PDE-5 inhibitors, which could enlarge the range of medications to choose from for the treatment of impotence. Below is the summarizing overview of upcoming medications, which are either approved for the treatment of ED in certain countries of the world, or are on different stages of clinical trials necessary for receiving the “green light” from the FDA.

Udenafil, manufactured by the Dong-A Pharmaceutical Co Ltd, is the first medication in our review because it is already approved for the treatment of ED in Korea and is sold in several countries under the brand name Zydena. Besides, this medication is likely to get the FDA approval as soon as the next year, since the final Phase 3 udenafil clinical studies are currently under way in the USA.

Zydena, which entered the Korean market in 2005, is produced in two forms of tablets for oral administration: with 100- and 200-mg of active ingredient. Available clinical trials data show that Zydena is effective in improving erectile function – about 48% of all the participants achieved normal erectile function after 12 weeks of treatment with udenafil. It is also reported that Zydena significantly increases the rates of successful penetration (up to 95%) and intercourse completion (up to 76%).

The safety profile of a new medication is also very promising. Mild to moderate facial flushing and headache are indicated as the most typical side effects, associated with Zydena use. Besides, the manufacturer underlines the fact, that Zydena does not cause myalgia, which sometimes accompanies treatment with the popular and widely used ED medication Cialis.

Avanafil from Vivus, California, is another anti-impotence medication which is currently under development. In year 2005 the company completed Phase 2 of clinical studies necessary for getting the FDA permission to start commercial marketing of the product. At that time many news portals published information on avanafil. Many experts suggested that the new ED medication may enter the market as soon as in 2007. However, since then there was no new information referring avanafil on the official web site of Vivus, so it is still unclear whether they initiated the final Phase 3 clinical studies or not. The information on the results of the Phase 2 studies of avanafil can be accessed at the following address http://www.epillz.com/info/avanafil-trials.html

Investigational drug, known as SLX-2101 from Surface Logics, has already been mentioned in one of our previous articles (http://www.epillz.com/info/surface-logix-tests-new-impotence-pill.html). The scientists from Surface Logics developed this chemical as a remedy for many cardiovascular disorders, such as hypertension and Raynaud’s disease, and not only for treating erectile dysfunction.

For the time being the medication is on the second stage of clinical trials in the USA. In June 2007 the Company reported about the initiation of Phase 2a clinical trials of SLX-2101 in patients with hypertension and Raynaud’s disease.

Meanwhile the company underlines the long-acting profile of SLX-2101: the interim data confirmed the activity of the medication during 48 hours after administering a single 10-mg dose of SLX-2101.

So, in spite of very promising results from different clinical trials, that foresee the appearance of new anti-impotence medications in the nearest future, it seems unlikely that in the next few months the hegemony of Viagra, Levitra and Cialis on the ED market will be disturbed by some newcomers.

Nick

External resources
http://www.vivus.com/main.taf?p=3,3,2,1
http://www.docguide.com/news/content.nsf/news/8525697700573E18852570C90062CE3...
http://www.surfacelogix.com/news/index.htm