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New Hope for Female Viagra

Viagra has a long history of helping men overcome erectile dysfunction.

Viagra has a long history of helping men overcome erectile dysfunction.

Viagra has been around for more than 15 years.

Several drugs that work similarly in helping men have better erections have been introduced to the market since Viagra was invented. Yet there is no comparable medication for helping women have more enjoyable sex. Viagra has been tested in women, but its effects weren’t impressive enough to make Pfizer paint it pink and start marketing it to women. Some women do have problems with sexual arousal that result from inadequate blood flow – similarly to how erectile dysfunction in men often results from insufficient blood flow to the penis. But in most cases, sexual dysfunction in women is more nuanced and complicated.

In 2010, a German drug company called Boehringer Ingelheim gave up on a drug called flibanserin after it was rejected by the US Food and Drug Administration (FDA). A North Carolina company called Sprout Pharmaceuticals bought it and has been trying to gain FDA approval for it ever since. But the FDA has rejected it twice more since 2010.

Why the FDA Wanted More Data

The FDA rejected flibanserin because, they say, it simply doesn’t work that well, and the evidence that the drug’s benefits outweigh its risks is not that strong. Unlike Viagra, which affects blood flow to the male sex organs, flibanserin acts on another sex organ: the brain. By rebalancing the levels of neurotransmitter chemicals dopamine and serotonin in the brain, Sprout Pharmaceuticals says flibanserin increases desire for sex in premenopausal women who have a condition called hypoactive sexual desire disorder (HSDD).

In 2014, the FDA told Sprout Pharmaceuticals that they could resubmit the drug for FDA approval, but they needed to include results of studies concerning driving ability after taking the drug, because sleepiness is a side effect of flibanserin. Sprout submitted the driving study data the FDA asked for in mid-February.

How Confident is Sprout Pharmaceuticals About FDA Approval?

Sprout Pharmaceuticals hasn’t given up on gaining FDA approval for flibanserin. In fact, they appear to be confident that the FDA will approve the drug, because they have taken the step of selecting a manufacturer for it. On March 4, Sprout issued a press release saying it had reached an agreement with UPM Pharmaceuticals to manufacture flibanserin 100 mg tablets in their 475,000 square-foot manufacturing facility located in Bristol, Tennessee. UPM specializes in solid dosage drugs (capsules and tablets) taken orally, as well as semi-solid creams and ointments.

Cindy Whitehead, Sprout Pharmaceuticals CEO, after signing on with UPM, said, “Sprout believes that, upon approval, Flibanserin will provide the breakthrough that women’s healthcare so richly deserves, and we are confident that UPM will be one of Sprout’s valuable partners in the production and distribution of this first in class, first in disease treatment product.”

Re-Framing Low Libido as a Feminist Issue

One way that Sprout has drawn attention to its struggle to gain FDA approval is by framing the FDA’s actions in light of feminism, saying that the fact that there are so many drugs available to treat sexual dysfunction in males, and none for females, shows that the government doesn’t care about female sexuality.

The FDA, however, hotly denies that it’s anti-feminist, and states that the reason they didn’t approve the drug was because it didn’t work that well and there were questions about side effects. If flibanserin is approved, it will become the first and only prescription medication approved in the US for treating HSDD.

Why Viagra and Flibanserin Are Fundamentally Different

Flibanserin affects brain chemicals, unlike Viagra, which affects blood flow.

Flibanserin affects brain chemicals, unlike Viagra, which affects blood flow.

Viagra and other drugs like it are known as PDE-5 inhibitors. By inhibiting the action of an enzyme called PDE-5, blood vessels leading to the penis are able to open up, permitting better blood flow and, if there is sexual stimulation, an erection. In other words, Viagra and its pharmaceutical cousins work on hydraulics. That’s why Viagra has been used to treat other disorders that are caused by blood flow problems, like pulmonary hypertension.

Flibanserin, on the other hand, isn’t taken as needed the way Viagra is, but is taken daily, long term. Sprout says the drug rebalances brain chemistry in such a way that women want sex more, and find sex more satisfying when they take it.

Other Companies Working on Treatments for Low Sexual Desire in Females

Other drug companies are working on treatments for HSDD. Canadian drug manufacturer Trimel is developing a nasal gel called Tefina, which is a low-dose formulation of testosterone for women who experience a condition called Female Orgasmic Disorder. This drug would be taken on an as-needed basis in women who have problems achieving orgasm and experience personal distress associated with it.

New Jersey-based Palatin Technologies is another company that is trying to develop a medication for treating HSDD. Its product, bremelanotide, is a synthetic peptide analog of a naturally occurring hormone called alpha MSH (melanocyte-stimulating hormone). It was originally studied as a sunless tanning product, when it was found to cause sexual arousal as a side effect. Early trials raised questions about effects on blood pressure, but a recent formulation is given subcutaneously (under the skin), and is supposed to have less of an effect on blood pressure. This drug is currently in phase 3 clinical trials in the US and Canada.

Conclusion

No one can deny that men who experience sexual dysfunction have many more medical options available to them than women with similar complaints. Whether this is simply a matter of technology or has to do with social views of male versus female sexuality is heavily debated. If Sprout Pharmaceuticals is successful in getting FDA approval for flibanserin, the company is ready to go with a manufacturer as soon as it gets the go-ahead. That may or may not happen in 2015, depending on the FDA’s actions. Other drug companies are working on possible treatments for female sexual dysfunction, but there’s no predicting how long that will take, since the FDA is not yet involved.

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Don Amerman has spent more than three decades in the business of writing and editing. During the last 15 years, his focus has been on freelance writing. For almost all of his writing, He has done all of his own research, both online and off, including telephone and face-to-face interviews where possible. Don Amerman on Google+