The long-awaited breakthrough in women’s sexual dysfunction may be here. German drugmaker Boehringer Ingelheim (BI) GmbH claims to have made a pill that will awaken female sexual desire.

This Prince Charming of investigational compounds promises to arouse Cinderella by decreasing inhibitions. This experimental desire drug plays with her mind literally, working on the brain.

Known as Flibanserin, this magic pill has sexual medicine bracing itself for a Viagra-like reception of this first of its kind pharmaceutical treatment for her. With women likelier to report sexual problems than men, sales for the U.S. market alone are projected to surpass the $2 billion Americans spend on erectile dysfunction treatments.

Before the money starts rolling in, however, it will take the U.S. Food and Drug Administration 6-18 months to decide whether it will approve Flibanserin.

Still, should you be more concerned than hopeful over its promise to transform women’s sex lives?

Flibanserin was originally researched as a possible treatment for depression and not as a possible contestant in the race for a “female Viagra.” While it didn’t lift users’ moods, researchers noticed that sexual appetite was rated consistently higher on measures of well-being. This prompted BI to conduct three separate, 24-week clinical trials investigating its potential to treat hyposexual desire disorder, which in laymen’s terms translates to a low-libido.

The more than 5,000 female participants recruited in the U.S. and Europe were mostly professionals in their early 30s to mid-40s in stable, monogamous, communicative, heterosexual relationships with a sexually functional partner. They were concerned, bothered, or frustrated with their low desire or its negative impact on their relationships.

Upon starting the treatment, they were asked to gauge their “satisfying sexual events.” They were beeped once daily and asked to rate their desire, as well as note whether they had been sexually active that day and if it was enjoyable.

Findings revealed an increase in the number of satisfying sexual events and sexual desire while distress due to hyposexual desire disorder decreased. These satisfying events included sexual intercourse, oral sex, masturbation, or genital stimulation by one’s partner.

Sounds great, right? Before getting too excited, though, consider the controversial issues at hand.

Even prior to its press blast Monday, BI was finding itself in the middle of the debate on how to deal with low or no libido. Can it be as simple as popping a pill? Or do the often multiple and complex issues involved require a more thoughtful, holistic approach?

Regardless, is a lack of interest in sex a true medical condition? Is there even a disorder to treat to begin with? Decreased desire may serve an evolutionary purpose, for example, enabling females to take care of their offspring.

Female sexual dysfunction has been criticized for being a “disease” created by pharmaceutical companies to make healthy individuals believe they have a problem requiring medicine. Who is to say that it’s dysfunctional, especially when there can be other factors at play?

A person’s relationship, beliefs, values, feelings, comfort level, and motivations, as well as a host of other issues, may be to blame — not the body or brain.

Proponents for the drug argue that decreased female desire is all in her head — a brain dysfunction of sorts.

Regardless of which side you’re on, there are other unavoidable issues that must be attended to, like:

BI researchers don’t know how Flibanserin works. They don’t know why it failed as an antidepressant. They’re guessing on why it helps female libido. Relying on a model of sexual excitatory and inhibitory structures in the brain, they’re unable to pinpoint how or where Flibanserin acts.

What we do know is that Flibanserin is a serotonin drug, with the same 5-HT1A chemistry as Buspar (buspirone), an anti-anxiety drug that functions differently than traditionally anti-anxiety meds like Valium and is said to be nonhabit-forming. Flibanserin works by blocking the release of serotonin, a brain chemical which regulates mood, memory, sleep and appetite.

After 3-6 weeks of daily 100 milligram use, the brain’s production of the neurotransmitter dopamine should increase, stimulating desire. While that sounds fancy and seems to make sense, nobody knows what this drug is treating exactly. We also don’t know the implications, including the brain altering effects, of this psychoactive drug.

The difference in research findings between continents hasn’t been explained. While significant differences were found between those taking the drug versus those using the placebo in North America, the European trials found no significant increase in sexual satisfying events between its two comparison groups. Answering this question stands to open a whole can of worms, including how an individual measures desire.

Even the researchers involved in the studies admit that sexual desire is difficult to define. What is “normal” sexual desire? Right now, there is no baseline by which to define low desire disorder.

Why didn’t sexual desire diminish post-trial? BI has yet to explain why participants who took the drug reported that sexual desire didn’t diminish after the study concluded. This begs questions like did Flibanserin permanently affect participants’ brain chemistry? Or was brain chemistry not a significant factor in most low desire cases?

The drug’s long-term safety and potential withdrawal problems are unknown. Right now, we don’t know the safety of the drug beyond 6 months of use. Side effects in the first two weeks of trials included dizziness, fatigue, anxiety, nausea, daytime sleepiness, dry mouth, and insomnia. The majority of these were resolved with continued treatment, though it’s worth noting that 15 percent of participants discontinued treatment because of the side effects.

Despite studying the drug for over a decade, BI has yet to publish clinical test results proving the drug’s effectiveness. It does, however, need to wrap up its research, and may be able to respond to the red flags being raised.

With most women in the study stating that low desire had “crept up” on them over time, you or your partner may want to keep that in mind if chronic low desire is ever experienced.

Instead of reinforcing the “it’s all in her head” stereotype about females, consider drug-free strategies to get to a better place. These may include becoming more sexually informed, evaluating one’s contraceptive use, therapy, and/or cultivating better communication and a healthier relationship (or getting out of one).

Dr. Yvonne K. Fulbright is a sex educator, relationship expert, columnist and founder of Sexuality Source Inc. She is the author of several books including, "Touch Me There! A Hands-On Guide to Your Orgasmic Hot Spots."

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