Erectile Dysfunction Pill for Men with Diabetes Enters Phase 3

ED is a common affliction among men with diabetes.

Feb 24, 2009

Avanafil, a pill that may permit diabetic men who are experiencing erectile dysfunction to engage in intercourse without the restrictions on food or alcoholic intake associated with other ED treatments, is entering a second phase 3 study-the crucial step before a drug manufacturer seeks FDA or European approval to market.

The drug, produced by the Mountain View, California-based company VIVUS, is described as a fast-acting, selective, oral phosphodiesterase type 5 inhibitor. VIVUS produces drugs aimed at treating obesity and sexual dysfunctions. 

ED is a common affliction among men with diabetes. The inflammatory disease often damages the vascular system, hampering the supply of blood to the penis that allows it to become erect. Data show that at least 50 percent of men with diabetes experience ED and that they are up to three times more likely than nondiabetic men to have ED. 

In the upcoming study, called REVIVE-Diabetes, approximately 375 type 1 and type 2 men who meet the criteria for participation will undergo four weeks of non-treatment followed by 12 weeks of treatment at 30 centers across the United States.

In the previous phase 2 study of Avanafil, 284 patients received the drug or a placebo. The efficacy of the drug was based on measuring the percentage of erections it induced that were sufficient for vaginal penetration and the percentage of erections lasting long enough for successful intercourse.

The drug produced erections sufficient for vaginal penetration 76, 79, 80, and 84 percent of the time with doses of 50, 100, 200, and 300 mg respectively. Erections lasting long enough for successful intercourse occurred in 54, 59, 62, and 64 percent of attempts with the respective doses noted above.

Subjects were asked to attempt intercourse 30 minutes after taking the pill, regardless of what food or alcohol they had consumed. The most common adverse event subjects experienced was headache, and there were no visual side effects from the drug. If the phase 3 trial goes well and Avanafil reaches market, VIVUS may offer it as a twice-daily treatment for men who would like to have intercourse more than once a day.

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Categories: Diabetes, Diabetes, Food, Medications Research, Professional Issues, Sexual Issues, Type 2 Issues


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Comments

Posted by Anonymous on 24 February 2009

Impotency is a serious issue little spoken of by the majority of sufferers. That's why I am choosing to let as many people as possible know about Butea Superba an herb grown under government license in the Far East and previously unavailable in the West. Butea relaxes the muscle in the walls of smaller blood vessels enabling increased blood flow particularly in the genital area. This can be visually obvious as some men experience erections that are noticeably bigger. I have located a pill version at www.healthyed.co.uk and you can see from the site there are clinical trials which improve erectile function in over 80% of men who take it. If not for your own sake then try them for the sake of your partner and put the physical back into your relationship.

Posted by Anonymous on 2 March 2009

Why is it always men? We ladies have problems in this area related to the diabetes- and NOTHING is done for us!

Posted by Anonymous on 2 March 2009

Is the new erectal disfuntion pill for people with diabetes available on priscription only?

Posted by ExhiltExcah on 5 April 2009

female infertility The side effects described in this factsheet will not affect everyone and may be different if you are taking more than one drug. The trademark owner does not need to provide the specific URLs in question. Less serious side effects may include: mild heartburn, nausea, or stomach upset; diarrhea, gas, or constipation; mild joint or back pain; or headache. Degradation of fosamax and osteonecrosis blood pressure. Curious bluish tinge have.

Posted by Anonymous on 11 April 2009

Benign prostate hypertrophy also known as benign enlargement of prostate is a condition seen in middle aged men and elder men in which there is increase in the size of prostate. There is hyperplasia of prostate stromal cell and epithelial cells leading to formation of large nodules in the peri-urethral area of the prostate.


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