Look Out Boys, It’s Our Turn

Is that a fire in your pocket ladies? Or is it just a dose of ‘Female Viagra’? That’s right, it has been approved..

The first drug to treat sexual dysfunction in women has been given the green light from the US Food and Drug Administration.

Hello, Addyi.

After a long dry wait, there can finally be an even playing field between men and women when it comes to enhancing a low sexual drive. Manufactured by Sprout Pharmaceuticals, the product is Flibanserin and the brand name is Addyi.

Personally, I think something like Yeehah would have been a better suited name…but maybe it means that somewhere in the world? The drug should be taken once a day in 100-mg doses just before bed, the FDA instructs, while patients should stop taking it if they haven’t had any fun after eight weeks. It sounds simple, but as we know with all things downstairs, it’s not.

The FDA reached their decision yesterday after the drug was knocked back more than once due to safety concerns.

But like a well-Viagraed penis, the drug and its campaigners have been hard to keep down. Two-well funded media campaigns, entitled Even The Score and Women Deserve, set about engaging women’s groups, pushing petitions and lobbying policy makers on the issue.

The figure “26-0” stood tall as a catch cry in reference to the 26 FDA drugs on the market for male sexual dysfunction, compared to none for women.

Many believe yesterday’s approval, which comes 17 years after Viagra made it onto the market (that’s a long foreplay…), gives hope to women who have hypoactive sexual desire disorder (HSDD) – a condition characterized by low sexual desire.

“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” FDA research director Dr. Janet Woodcock said.

“The FDA strives 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.”

Female Sexual Dysfunction?

The FDA conducted three randomized, double-blind, placebo-controlled trials involving around 2,400 women of an average age of 36 years who had HSDD.

For a 24-week period, the women took either a placebo or a 100-mg dose of flibanserin before bedtime. The women who took flibanserin reported a modest increase in sexual desire and sexual events during the study period, as well as a reduction in distress as a result of low sexual desire.

These also came with reports of nausea, dizziness, fatigue, sleepiness, insomnia and dry mouth as side effects alongside hypotension – severely low blood pressure – and loss of consciousness, particularly if taken with alcohol (do you need both in your life..?).  Such side effects led the FDA to reject the drug twice – once in 2010 and again in 2014.

Yesterday’s approval was the much-awaited climax for those who felt the agency was discriminating against the sexual health of women, but a definite miss for those who believe the gate is now open for bullied attempts to put an ineffective and unsafe drug on the shelf.

Pharmacology professor Adriane Fugh-Berman believes since the last disapproval, the drug actually has more risks and fewer benefits than first thought.”The only thing that’s different is a clever, aggressive public relations campaign that Sprout Pharmaceuticals waged successfully,” she told The Washington Post. “This opens the way for drug companies to pressure the FDA through public relations campaigns to approve more bad drugs: It’s bad news for rational drug approval,” she added.

What are the risks?

But the FDA’s approval comes with a small compromise- a risk evaluation and mitigation strategy requires that all prescribers enroll in and complete a training program before treating patients with the drug.

“Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies,” Dr. Woodcock said. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment.”

In addition, a Boxed Warning is being applied to flibanserin, informing patients about the risk of hypotension and concussion if taken with alcohol, as well as warning patients with liver impairment or those taking moderate or strong CYP3A4 inhibitors to avoid use of the drug.

Psychological factors, such as low self-esteem, stress or mental health problems may contribute to low sexual desire, as well as hormone changes or physical factors like fatigue. Around one in ten women develop HSDD, and up to 40% experience the condition at some point in their lives.

While the exact mechanisms by which Flibanserin works is unclear, Sprout Pharmaceuticals believe it corrects an imbalance in brain chemicals that are responsible for sexual desire. There is now an option for women to combat this problem, albeit with some safety concerns.

Either way, look out boys there will now be some stiff competition in the bedroom…

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