Should We Be Calling Flibanserin Female Viagra?

On August 18, the US Food and Drug Administration (FDA) approved flibanserin, a drug designed to address sexual dysfunction in women.

The drug, which will be sold as “Addyi” (possibly the only word more confusing to pronounce than flibanserin), will be available by prescription to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in women who have not yet gone through menopause. It is the first FDA-approved treatment for a sexual desire disorder for either sex.

In a statement, the FDA said that they strive “to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.” HSDD is defined as low sex drive that causes personal distress or interpersonal difficulty and is not due to:

• Co-existing medical conditions
• Psychiatric conditions
• Relationship problems
• Effects of medication

It’s considered “acquired” when it develops in someone who didn’t have problems with sexual desire previously. “Generalized” means that it occurs regardless of situation, type of sexual activity, or partner.

How Viagra Works

Viagra, the treatment for erectile dysfunction (ED) in men, has been around since 1998, and it works by addressing the problem of insufficient blood flow to the penis. Viagra doesn’t cause erections all by itself, but makes them possible in men who have decreased blood flow due to increased age, cardiovascular disease, obesity, diabetes, or other issues that affect blood vessel function. It’s taken on demand, and the effects wear off after several hours.

How Flibanserin Works

Flibanserin affects several brain chemicals that are associated with mood and appetite. The compound was originally studied as a possible treatment for depression, but it didn’t work that well as an antidepressant. No one is really sure exactly how flibanserin increases sexual desire, but researchers know that it increases dopamine, which is a brain chemical associated with appetite and motivation. At the same time, it lowers levels of serotonin, which is a brain chemical associated with feelings of satisfaction.

In other words, flibanserin works in an entirely different manner than Viagra. It works on brain chemistry rather than the walls of blood vessels, so calling it “female Viagra” is somewhat unfortunate. But the nickname is not altogether unexpected either, since the drug, like Viagra, will be the first that’s FDA approved for treating sexual dysfunction in women, and Viagra has become shorthand for “enables sexual activity.”

Comparison Chart: Flibanserin vs. Viagra

Here is a brief summary of the differences between flibanserin and Viagra.

	Flibanserin	Viagra
Designed to affect sex drive?	Yes	No
Designed to affect blood flow?	No	Yes
Short or long term effects?	Long	Short
How taken	Daily	As needed
Targeted patient age range	Pre-menopausal	Adult men, no upper age limit
Side effects	Dizziness, nausea, fatigue	Headache, indigestion
Cost and insurance coverage	$30-75/month depending on coverage	$30-40 per pill, insurance coverage rare
Availability	Mid-October 2015	Since March 1998

Why the FDA Finally Came Around on Flibanserin

Flibanserin was rejected by the FDA twice before. In 2010, the FDA noted that the compound did not achieve the key goal of increasing desire based on what was reported in patients’ daily journal entries. Hence, they believed the drug’s side effects outweighed its benefits. After that, Sprout Pharmaceuticals, which bought flibanserin from a German company in 2011, conducted another study of sexual desire using scoring that would make it easier to calculate statistical significance. That wasn’t enough either, and the FDA rejected the drug a second time, saying they needed more safety data – particularly data on how flibanserin affects driving ability.

Sprout conducted specific safety studies along with other clinical trials before submitting the results to the FDA once again. This time, the FDA granted approval, but not without controversy. Critics have speculated that lobbying by people in support of Sprout Pharmaceuticals and by those decrying the lack of sexual dysfunction drugs for women swayed the FDA, though the FDA is required to make all their decisions based on scientific evidence.

Alcohol and Flibanserin Don’t Mix

One of the biggest unknowns is how big a factor alcohol will play in prescribing and use of flibanserin. Alcohol poses the potential for serious interaction with the drug, so flibanserin will only be prescribed by certified healthcare professionals and dispensed through certified pharmacies. Women are warned not to drink alcohol while taking flibanserin, and since flibanserin is taken every day long term, that means abstaining from alcohol for however long a woman takes the drug. This may prove to be too big a trade-off for some women to consider.

And the effects of alcohol on those who take flibanserin are serious. It can cause blood pressure to drop enough to cause fainting, which is particularly significant in a drug where the FDA specifically ordered the manufacturer to conduct driving safety studies. Even though the drug has FDA approval, Sprout must conduct three more studies on how flibanserin interacts with alcohol.

Will the Nickname “Female Viagra” Stick?

Whether they think flibanserin marks a breakthrough in treating sexual dysfunction in women, or whether it “medicalizes” something that isn’t really a medical problem, researchers and doctors agree that “female Viagra” is a misnomer. Flibanserin may, unfortunately, be stuck with the nickname, at least until the drug proves itself to help women have more satisfying sex drive and develops its own positive reputation (and possibly its own, non-Viagra-related nickname). If the drug doesn’t do well on the market, calling it “female Viagra” won’t really matter, because few people will be using it.

Conclusion

HSDD is believed to affect between 5 million and 9 million women in the US in the 20- to 49-year age group. That’s a lot of women with the potential to embrace a medical treatment for their low sexual desire. In women in particular, a huge range of factors affect sexual desire, including many that have nothing to do with physiology (like the many distractions of raising young children). It remains to be seen how successful flibanserin is in genuinely helping women with HSDD. Right now, the drug is expected to be introduced to the market in mid-October.

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