New “Fast-Acting” ED Drug in Phase 3: Tests on Men with Diabetes

What is and is not acceptable in polite society changes at warp speed sometimes.  One prime piece of evidence is the availability of information and a variety of treatments for erectile dysfunction.  This comes to mind particularly because Mountain View, CA-based Vivus Inc (Nasdaq:VVUS, announced last week that it is in a pivotal Phase 3 study of about 375 patients at about 30 sites in the US concerning its drug, Avanafil, which is said to be “fast-acting,” in addition to all the other things that ED drugs are supposed to be.

Unlike the furor that accompanied the first ED drugs when they were on the path to approval, the news of Avanafil tests does not seem to have sent VVUS shares skyrocketing.  The stock is trading today (in a bad market, admittedly) at $4.31, off $0.26 on lighter-than-usual volume.  VVUS itself has a market cap of just under $300 million, less than half what it was at its yearly high.

Interestingly this pivotal study is entirely devoted to men who have diabetes.  According to the Valentines Day (coincidence?)  edition of Science Daily, “Diabetes and high blood pressure restrict blood flow to the penis, leading to erectile dysfunction.”

It is possible that the ED news is completely subsumed by the fact that the study is devoted to diabetics?  Does it seem that an aphrodisiac (OK, that is what these things are, after all) for someone whose pancreas doesn’t deal well with insulin is not part of the mainstream? 

According to the Vivus news release, there has not been a new treatment option for men with ED in more than five years.  And today, ED drugs are bringing in $3.7 billion a year (and there are only 3 of them).  It is said that 35% of men between the ages of 40 and 70 are afflicted with ED.

According to the American Diabetes Association, there are 23.6 million Americans with diabetes, or 7.8% of the entire population of the country.  Some 5.7 million of those people are undiagnosed (unaware that they have the condition).

Although diabetes can be a prime cause of ED, there are numerous other things that can be implicated, as the Science  Daily  article points out,  particularly bad habits and conditions that we ALL know we ought to pay more attention to: cigarettes, obesity and high cholesterol, largely quoting Temple University urologist Jack Mydlo. 

WebMD points out that there are various non-drug “alternative” treatments for ED, to wit vitamins and food supplements (arginine, bioflavanoids, zinc, vitamins C & E and flax seed, for example); acupuncture; and a variety of herbal remedies such as gingko biloba and ginseng root.

Not to be outdone, by the way, the ag community, represented by Texas A&M,  has now found that watermelon is rich in an amino acide called citrulline, which ALSO dilates and relaxes blood vessels like the well-known Rx drugs, Viagra, Cialis and Levitra.  (  As with almost all nondrug claims, however, there are people who pooh-pooh watermelon’s potential for potentiation. 

Not to put too fine a point on the issue, diabetes research as a whole can lead an investor to lots of interesting small companies.  The ADA maintains a database of research:  And there are some very distinctive smallcaps who have staked their futures on diabetes research.  That includes Stockholm-based Diamyd Medical, which announced this week that it will conduct Phase 3 trials of its diabetes vaccine. concentrating on children and adolescents (  Diamyd shares trade on the OMX, but its ADRs are on the Pink Sheets (OTC: DMYDY,  The last trade was last month, and the last price was $7 vs a year-high of $15.15, but shares bought on the OMX can be turned to US-tradeable ADRs (ask your broker or talk to Bank of NY Mellon, the depositary bank for Diamyd).


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