The protracted battle to win approval for the first prescription drug to treat female sexual dysfunction is finally over. Now that the dust has settled, it’s time to take a closer look at exactly how the little pink pill known as Addyi works and which women it is likely to benefit most.
Although female sexual dysfunction takes on a variety of forms, Addyi was designed specifically to help women who are suffering from hypoactive sexual desire disorder, or HSDD, which is said to affect roughly 10 percent of women. The Encyclopedia of Mental Disorders defines HSDD as “the persistent or recurrent extreme aversion to, absence of, and avoidance of all, or almost all, genital sexual contact with a sexual partner.” Although HSDD occasionally occurs in men, it is far more common among women.
Not All Women Qualify
In a recent article at WOODTV.com, Nisha McKenzie, a physician’s assistant at Grand Rapids OB/GYN, said many women who’ve asked for the drug at her office don’t really qualify for a prescription. She said that just because a woman doesn’t want to have sex on a daily basis, that doesn’t necessarily fit the diagnosis of HSDD. She suggested the following hypothetical to perhaps weed out those for whom the drug isn’t really appropriate:
If you don’t normally want sex on a daily basis but tend to feel more sexually active when you’re heading out on vacation, the odds are that you’re not suffering from HSDD. It’s more likely that fatigue and stress are reducing your interest in sex on a regular basis. And it’s unlikely that Addyi will change that dynamic significantly.
However, McKenzie told WOOD-TV that she welcomes the fact that the debut of Addyi has encouraged women to speak out about their sexual concerns, a topic that has all too often been avoided in the past. She expressed the hope that a more open conversation about women’s sexuality will open the doors to further scientific research that could eventually develop an even greater range of medications and therapies to help women. “Even if this [Addyi] doesn’t work for everyone, which it won’t, it’s a great groundbreaker. . . .”
For Premenopausal Women Only
McKenzie also pointed out that flibanserin — the active ingredient in Addyi — was tested exclusively on premenopausal women and was approved by the Food and Drug Administration for that group of women exclusively. Existing hormone replacement therapies have helped some postmenopausal women to increase their desire for sex in the wake of menopause.
As previously noted, Addyi is the first prescription drug that the FDA has approved for the treatment of HSDD, the most common form of female sexual dysfunction. In that respect, Addyi is comparable to Viagra, the first of a series of prescription medications approved for the treatment of impotence, one of the most common forms of male sexual dysfunction. In the years since its 1998 debut, Viagra has been followed to market by a handful of other drugs, all of which are similar in chemical structure and are known collectively as PDE5 inhibitors.
However, Addyi’s similarity to Viagra pretty much ends with the fact that each drug is a pioneer of sorts, offering a new type of treatment for a specific form of sexual dysfunction. The references to Addyi as “female Viagra” or “pink Viagra” are extremely misleading, because the two drugs work in very different ways.
How Viagra Works
Viagra and the other PDE5 inhibitors recognize that the vast majority of erectile dysfunction is physiological in origin, stemming from insufficient blood flow to the penis. These drugs offer a temporary solution to the problem, facilitating an increased blood flow to the pelvic region for four to 36 hours depending on your drug of choice.
By contrast, Addyi works in the brain to help fire up the libido in women who have lost their interest in and desire for sex. To help rekindle sexual desire, Addyi rebalances brain chemistry through its effects on two brain receptors that regulate serotonin, a neurotransmitter associated with decreased sexual desire. Of the two serotonin receptors in the brain, 5-HT1A puts the brakes on serotonin production, while 5-HT2A accelerates the rate of serotonin output. Addyi enhances the effects of 5-HT1A while at the same time inhibiting the effects of 5-HT2A.
As brain levels of serotonin decrease in response to Addyi’s effects, one of the side effects is a consequent increase in levels of dopamine and norepinephrine, two neurotransmitters that are believed to enhance sexual desire.
Onset of Effect Differs
Yet another difference between Addyi and the male erectile dysfunction drugs is the time it takes for them to become effective. Viagra and the other impotence drugs can be taken as needed, usually enabling men who take them to achieve an erection within 15 to 60 minutes after the drug is taken.
To be effective, Addyi must be taken daily, and its effects don’t begin to show up until two to four weeks after a patient has begun taking the drug. While neither Addyi nor Viagra works for all patients, clinical tests have shown that the male drug works for almost two-thirds of the men who have tried it. According to EverydayHealth.com, women who took Addyi in clinical trials experienced a 53 percent increase in sexual desire, as gauged by the Female Sexual Function Index. Participants in Addyi’s clinical trials also reported a doubling in their number of satisfying sexual events, and a 29 percent decrease in their concerns about sexual function.
Flibanserin was originally developed by German drugmaker Boehringer-Ingelheim, which decided to give up on the drug after the FDA in 2010 rejected the drugmaker’s petition to market the medication. Shortly thereafter, Boehringer sold the rights to flibanserin to North Carolina-based Sprout Pharmaceuticals. Over the next four years, Sprout worked tirelessly to win approval for flibanserin, which it planned to market under the Addyi brand name. Sprout’s efforts finally paid off in August 2015 when the FDA gave Addyi its thumbs-up, albeit with a number of strings attached.
Since it became available in October 2015, Addyi’s sales have been surprisingly slow to take off, which may be attributable in part to the conditions that the FDA attached to its approval. To be able to prescribe or dispense the drug, physicians and pharmacists must first be certified in the FDA’s REMS (risk evaluation and management strategy) program. This requirement was imposed by the FDA because of concerns about the risk of severely low blood pressure and loss of consciousness among some women taking the drug.
The regulatory agency also required that Addyi carry a boxed warning on its label and/or packaging inserts to warn prospective users that using alcohol while taking the drug significantly increases the likelihood of these adverse side effects.
To read more about Addyi, Viagra, and other related medical topics, click on this link to related content on our blog.
Don Amerman is a freelance author who writes extensively about a wide array of nutrition and health-related topics.
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