The little pink pill. The "female Viagra." It’s the pharmaceutical industry’s Holy Grail.

With well over a third of women suffering from at least one symptom of female sexual dysfunction, according to the UCSD Department of Family and Preventive Medicine, the market for a medication that effectively treats FSD actually is larger than that for male sexual dysfunction. Hence the contest among pharma companies to be first to bring the female sex drug to market. The winner will have a blockbuster med that will dwarf Viagra, which generates nearly $2 billion a year for Pfizer.

But the quest has proven far more daunting than drug makers originally expected. That’s because FSD is considerably more complicated than male impotence, which usually is successfully treated by increasing blood flow to the male package. It’s not that simple with women. Those diagnosed with FSD are not monolithic; they fall into one of four subtypes.

Most suffer from hypoactive sexual desire disorder — a persistent loss of libido — which is a "treatable condition," according to Dr. Thuy-Tien Dam, who led a team of UCSD researchers in a clinical trial for an investigative drug that aims to help women with HSDD. Next are those diagnosed with female sexual arousal disorder (FSAD), in which desire is not a problem but the genitals do not respond to sexual stimulation. A smaller cohort have anorgasmia, a lack of orgasm after normal arousal. Then there are those who suffer from sexual pain disorder, which is associated with intercourse and makes penetration particularly difficult.

Pharma companies have developed all manner of medical products to address the various FSD manifestations, including pills, creams, gels, patches and even a handheld vacuum device. But the quest for the female equivalent of Viagra has yet to produce a real breakthrough.

Few have been more involved in research and development of FSD therapies than well-known urologist Irwin Goldstein, the director of sexual medicine at San Diego’s Alvarado Hospital. He’s been at it since he helped ­Pfizer launch Viagra in 1998.

Pfizer actually funded clinical trials to see if certain women might benefit from taking Viagra. And Goldstein was one of a number of doctors around the country who prescribed the drug for his female patients diagnosed with FSD.

Goldstein saw some promise with Viagra for certain female patients. And at least one small study, reported in the Journal of the American Medical Association, concluded that the drug provided benefit to women with arousal issues. But Pfizer was not suf­ficiently persuaded by the results of its clinical trials to market the blue pill to women and withdrew from the pursuit in 2004. That left the multibillion-dollar market for an FSD med wide open. And many other pharma companies rushed in.

Procter & Gamble developed a patch, Intrinsa, which aimed to increase women’s libido by releasing testosterone through the skin into the bloodstream. While P&G claimed that the patch increased satisfying sexual episodes for women by 1.9 per month, Intrinsa failed to receive FDA approval.

Boehringer Ingelheim, a German drug maker, had high hopes for Flibanserin, a pill that also promised to increase the level of women’s sexual desire. Goldstein took part in the clinical trials, declaring that the drug has "enormous potential to be a life-changing sort of product."

Alas, while Flibanserin’s maker produced a study that claimed an increase by one per month in the number of self-reported sexually satisfying events for women using the pill (the events did not have to include orgasms), FDA staff rejected the drug last August. Boehringer has since stopped working on it.

That leaves LibiGel, developed by Illinois-based BioSante Pharmaceutical, as the FSD product closest to market. The testosterone cream, which treats hypoactive sexual desire disorder, is in the last three FDA-required human trials.

BioSante maintains that LibiGel is more effective than Procter & Gamble’s Intrinsa and Boehringer’s Flibanserin. But it remains to be seen whether the drug maker will have more success than its rivals did in winning FDA approval. And while LibiGel is further along in the regulatory approval process than any other FSD drug or therapy on the horizon, it hardly is the last best hope for the one-third of women afflicted.

With a potential market worth at least $5 billion, according to BioSante and other published reports, pharma companies will continue to invest substantial R&D dollars in hope of discovering the game-changing FSD treatment. It may be a single little pink pill. Or it just might be two or three or even four different drug or medical therapies, each of which will treat a different FSD subtype. But help surely is on the way for the tens of millions of women with female sexual dysfunction.

That’s a Valentine’s Day promise from the pharmaceutical industry.

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