Feb. 24, 2004 -- What could be bigger than a little blue pill that turned a common problem for the bedroom-challenged man into a marketing marvel, creating a $2.5 billion-a-year pharmaceutical niche that once featured a president wannabe as its prime-time pitchman?
Chris Every hopes it's a mint-flavored tablet for what may be an even more common problem than impotence. He's the CEO for Enhance Biotech, a company developing what could become the first pill specifically developed to treat rapid ejaculation -- the new name for premature ejaculation, one of the most common sexual disorders in men.
Because relatively few men seek professional treatment for premature ejaculation, it's estimated that about one in five guys are affected. That may be more than those with erectile dysfunction (ED). Rapid ejaculation occurs in virtually every man at some point in his life.
Since Viagra entered the market six years ago as the first ED oral agent, its success spawned two newer FDA-approved impotence drugs whose combined sales are estimated by some analysts to triple by decade's end -- to more than $6 billion annually.
Every's drug, currently known as LI 301, is still in development, and wouldn't hit the market until 2007, assuming it receives FDA approval. A recently completed preliminary trial involving 30 couples produced promising results, Every says. These study results have not been published.
Usually Treated With Antidepressants
While his drug would be the first especially for rapid ejaculation, SSRI antidepressants such as Paxil and Zoloft are currently used with impressive success. These drugs help men with rapid ejaculation because their typical side effects include delayed ejaculation.
Every says LI 301 offers several advantages to SSRIs.
"First, (SSRIs) are taken chronically and therefore you have all the widely recognized side effects and unpleasant features commonly associated with long-term SSRI use," he tells WebMD. "Second and more importantly, for this condition the recognized effect of SSRI buildup in the system is a loss of libido."
But Every says his drug, taken on an as-needed basis about two hours before intercourse, reportedly combines actions of SSRIs with drugs that produce an opioid effect that dulls sensation in the penis to prevent over-excitability. "There is no loss of libido or other effect on normal sexual activity."
In initial trials, Every says LI 301 delayed ejaculation to some degree in all men tested.
Experts: Wait and See
Two experts tell WebMD there is a huge market for a drug specifically to treat rapid ejaculation. While both say they've heard about LI 301, with no published data on its effectiveness, both are taking a "wait-and-see" view about it.
Meanwhile, both say they are satisfied with treating their patients with better-studied SSRIs.
"SSRIs for rapid ejaculation are administered at a low dose, so you don't really see the erectile dysfunction side effect in this use," says urologist Kenneth Goldberg, MD, founder of The Male Health Center in Dallas, the nation's first center specializing in male health. "And rapid ejaculators are more typically younger patients [who are less likely to become impotent]. In fact, I don't know of a single patient with rapid ejaculation who has ever complained of ED as a result of SSRI use."
Goldberg tells WebMD that with SSRIs, his patients can delay ejaculation for several minutes -- the same rate of delay seen in some of Every's patients. Untreated, rapid ejaculators typically climax within a few seconds of penetration or other contact.
"I certainly hope (LI 301) works, but it's too early to say," adds Harvard urologist Michael P. O'Leary, MD, MPH. "Its effectiveness depends on how specific it is to the (brain) receptors, and we'll have to wait and see how well it does. Meanwhile, SSRI efficacy has been demonstrated. They don't work on every man, but they do work on most."
SOURCES: Chris Every, CEO, Enhance Biotech, Inc., New York and London. Kenneth Goldberg, MD, urologist and founder, The Male Health Center, Dallas. Michael P. O'Leary, MD, MPH, urologist, Brigham and Women's Hospital; associate professor of surgery, Harvard Medical School, Boston.