It’s easy to understand why women in this country feel somewhat slighted by U.S. drug regulators and even Big Pharma. Thanks in particular to the PDE5 inhibitors, such as Viagra, on the market since early 1998, their male partners have had plenty of help in overcoming sexual challenges in the bedroom.
Women also experience sexual dysfunction, the most common manifestation of which is hypoactive sexual desire disorder, or HSDD. It’s estimated that 10 percent of all American women suffer from HSDD, which includes among its primary symptoms an absence of sexual fantasies and a lack of desire for sexual activity.
Frustration and Anger
Women are understandably frustrated and even angry that the U.S. Food and Drug Administration has thus far turned thumbs down on all medications proposed to treat HSDD. Even the Score, a women’s sexual health advocacy initiative, is pushing a petition to pressure the FDA to approve some form of treatment option for HSDD. The organization points out that the FDA has approved 26 drugs — including five PDE5 inhibitors — for the treatment of men with various forms of sexual dysfunction but not a single medication to help women.
As with any new medication — whatever that might turn out to be — questions arise about not just the benefits such a drug might offer for women but also what, if any, downside there might be.
Over the years, two primary approaches to treating female sexual dysfunction have been widely discussed. A formulation of Viagra designed specifically for women would mimic the effects of the drug for males by promoting strong blood flow to the female genitalia. The other primary approach to treating sexual dysfunction in women would cause subtle changes in brain chemistry to help fire up the female libido.
At present, women are pinning their hopes on the latter approach as provided by a drug called flibanserin, a non-hormonal drug designed to relieve the symptoms of HSDD in pre-menopausal women. The drug’s manufacturer, North Carolina-based Sprout Pharmaceuticals, is hoping that the FDA will soon give flibanserin the green light after rejecting prior requests for approval and asking for further testing.
Over 12 Years of Research
Cindy Whitehead, chief executive officer of Sprout Pharmaceuticals, recently told WNCN reporter Melanie Sanders that research into flibanserin has gone on for more than 12 years and has involved clinical trials with more than 11,000 women. Whitehead said Sprout will soon resubmit its application for flibanserin’s approval and hopes to win the FDA’s nod by late 2015.
Known unofficially as “female Viagra,” flibanserin’s little pink pills (a gender-appropriate color contrast to Viagra’s little blue pills) are still at least a year away from FDA approval. Nevertheless, observers are chiming in with their thoughts about possible drugs to treat HSDD and their likely benefits and drawbacks.
In an article posted at EmpowHER.com, writer Shaina Gaul offers an interesting review of some of the pros and cons that might be seen in a drug for women that works by increasing blood flow to the genitals, much like the PDE5 inhibitors for men. Here is a look at her views, contrasted with the likely pros and cons of flibanserin.
Pros of Female Viagra
On the positive side, Gaul notes that a true female version of Viagra could improve circulation and thus increase the energy level in women with certain conditions. Among such diseases and disorders, she listed autoimmune disorders like lupus, cancer, diabetes, heart disease, hypertension, neurological diseases, and thyroid disorders.
However, unlike the PDE5 inhibitors that work by optimizing blood flow to the male genitals, flibanserin works “works on key chemicals in the brain to basically increase desire and decrease distress,” Sprout CEO Whitehead says. “So it has a positive effect on the positives, and a negative effect on the negatives.”
Side Effects of Medications
Another benefit of a female version of Viagra, says Gaul, would be its ability “to counteract the loss the libido incurred as a result of certain medications.” She cites blood pressure medications and antidepressants as some of the big offenders in this area. Interestingly, these same medications can cause erection problems for men. Although flibanserin works on brain chemicals rather than blood flow, it is likely that it could help overcome the side effects of drugs such as those cited by Gaul.
In looking at the benefits of a female counterpart to Viagra — one that works primarily by improving blood flow to the vagina — Gaul speculates that it would likely make it easier for women to achieve orgasm. She says that increased blood flow would hopefully increase lubrication and relax the muscles of the vagina. It’s entirely possible that flibanserin’s subtle shifts in brain chemistry could also achieve such benefits, albeit via a different route.
Increasing Sexual Desire
Looking at some of the possible disadvantages to a female version of Viagra, high on the list for Gaul is its likely inability to increase desire. This obviously would not be a problem with flibanserin, which works on brain chemicals specifically to increase sexual desire.
Of a medication that would be a true female counterpart of Viagra by promoting blood flow to the female genitals, Gaul sought the opinion of Sandra Lieblum, director for sexual and marital health at UMDNJ Robert Wood Johnson Medical School in Piscataway, New Jersey. Lieblum observed that “what the genitals are doing may play a less important role in how a woman defines her sexual arousal. I don’t think there will ever be an aphrodisiac that will make [women] want to have sex all the time.”
Prohibitive Cost for Some?
Another likely disadvantage of a true female version of Viagra, says Gaul, would be its high cost, putting it out of reach for women of modest means. This, of course, might be equally true for flibanserin, assuming it eventually wins FDA approval, as Sprout would almost necessarily have to put a high price on the drug to recoup its sizable investment during more than a decade of research and clinical trials.
For those who might be hopeful that a female Viagra would be covered by their health plans, Gaul notes that “women’s sexual health products . . . have a long history of being controversial . . . which may prevent them from being covered by insurance plans.” There’s no reason to assume that health insurers would take any more kindly view of flibanserin, if and when it wins FDA approval.
Female Sexual Response
In an overview of the complexities of female sexual response posted at MayoClinic.com, Jacqueline M. Thielen, M.D., explains that increasing arousal, such as a female equivalent of Viagra might do, “may not get to the actual problem — which is often a lack of sexual desire.”
Dr. Thielen, who is associated with the famed health center’s Women’s Health Clinic, says a wide variety of factors influence sexual desire in women. High on the list of such factors, she cites:
- The stresses of day-to-day life tend to deplete a woman’s desire for sex.
- Fluctuations in sexual desire may be linked to relationship difficulties or other major life events, such as pregnancy and menopause.
- The elusive nature of orgasm for many women may contribute to “concerns or preoccupations that lead to a loss of interest in sex.”
- A woman’s level of sexual desire is often closely tied to her past sexual experiences as well as her sense of intimacy with her partner. “Over time, psychological troubles can contribute to biological problems and vice versa.”
- The female sexual-response cycle can be negatively affected by such chronic conditions as diabetes and multiple sclerosis.
Don Amerman is a freelance author who writes extensively about a wide array of nutrition and health-related topics.
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