What You Really Need to Know About ΓÇ£Pink ViagraΓÇ¥

By Sondra Forsyth

In the wake of a media frenzy over the FDA’s advisory committee vote on June 4th 2015 in favor of approving so-called “Pink Viagra”, thirdAGE is here to give you a digest of the facts about the drug that’s being promoted as a female libido booster.

Is ΓÇ£Pink ViagraΓÇ¥ an apt nickname for flibanserin (pronounced fluh-BAN-ser-in)?

Not really. The moniker is catchy and clicky, but comparing the little blue pill that sends blood flow so guys can achieve erections and a little pink pill that acts on neurotransmitters in womenΓÇÖs brains is a classic example of comparing apples and oranges. According to Marie Savard M.D., ΓÇ£Whereas men pretty much have an on/off switch, women’s sexual function is much more complicated. Treating lack of desire with a neurotransmitter modulator may be a bit of a shotgun approach that helps some women but not others. It doesn’t really address the varying issues women face. We are just not that simple!ΓÇ¥

Does the advisory committeeΓÇÖs 18 to 6 vote for approval guarantee that the FDA will approve flibanserin by the August 18th deadline?

No. The agency typically follows the recommendations of its advisory committees, but not always. In this case, the approval came with a proviso specifying that steps must be taken to reduce known risks. Not only that, but many of the committee members who finally cast yay votes had expressed reservations about doing so. Consequently, there’s a possibility that final approval will be denied.

Is this the first time a manufacturer has sought FDA approval for flibanserin?

No. In 2010, an FDA advisory panel voted unanimously against recommending approval of flibanserin. The manufacturer at that time, Boehringer Ingelheim, stopped developing the drug. Then in 2013, Sprout Pharmaceuticals took over and submitted the drug for approval a second time. The FDA responded by requiring further studies of flibanserin. The company complied before submitting an application for approval once again in 2015. (For the record, flibanserin was originally developed as an antidepressant but it didnΓÇÖt prove to be effective for that purpose.)

You mentioned ΓÇ£known risksΓÇ¥. What are they?

Two worrisome side effects are low blood pressure and fainting. In one case, a woman ended up with a concussion after she fell. Nausea and dizziness have also been reported. In addition, the side effects are heightened if a woman drinks alcohol, uses birth control pills, or takes anti-fungal medications to treat vaginal yeast infections. The FDA might require physicians to inform patients of the possible side effects. There is also a chance that the FDA will require certification to prescribe flibanserin. Beyond all of that, women have to take flibanserin every day so the long-term systemic effects are not yet known. In contrast, men take Viagra ΓÇô or for that matter, Cialis or Levitra ΓÇô only when they are in the mood but need a remedy for erectile dysfunction.

Viagra was approved 17 years ago in 1998. Why has it taken so long to get approval for a drug to improve womenΓÇÖs sex lives?

The answer goes back to the answer to the very first question about the difference between the sexuality of men and women. Viagra treats erectile dysfunction, a physical reduced blood flow problem, but it does not treat low sexual desire. If a guy isnΓÇÖt in the mood, chances are the little blue pill wonΓÇÖt have any effect!

A campaign to get approval for flibanserin waged by a group called ΓÇ£Even the ScoreΓÇ¥ accused the FDA of gender bias. Notably, though, the group was supported financially by Sprout, the current manufacturer of flibanserin, and Sprout paid travel expenses for women to come to the approval hearing to testify in favor of flibanserin. Andrew Pollack in an article for The New York Times noted that at least one of the women testifying, Katherine Campbell from Indiana, had not tried flibanserin.

Also, womenΓÇÖs groups including the National WomenΓÇÖs Health Network have urged the FDA to override the recommendation of the advisory committee out of concern for womenΓÇÖs safety.

Is flibanserin effective?

Many detractors of flibanserin have pointed out that for all the fuss, the drug doesnΓÇÖt do all that much to heighten womenΓÇÖs sex drive. In an article for the web site Vox: Science and Health, Julia Beluz wrote: ΓÇ£Dr. Adriane J. Fugh-Berman ΓÇö the director of the PharmedOut project at Georgetown University ΓÇö testified at the committee hearing, calling flibanserin ΓÇÿa mediocre aphrodisiac with scary side effects.ΓÇÖΓÇ¥ Later Fugh-Berman said to Beluz, ΓÇ£Marketing won over science today.ΓÇ¥

Regarding the Sprout trials, Pollack wrote in The New York Times: ΓÇ£The women who took part were having an average of two to three of what they defined as ΓÇÿsexually satisfying eventsΓÇÖ per month when the studies began. Once they started taking the drug, the number of such events increased, but by only about one event per month more than for women in the trial who got a placebo.ΓÇ¥

Is flibanserin meant for women of any age?

The current manufacturer, Sprout Pharmaceuticals, was only seeking FDA approval for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women, meaning those under the age of about 52. Even so, a multi-university study published in 2014 in Menopause: The Journal of the North American Menopause Society concluded that ΓÇ£in naturally postmenopausal women with HSDD, flibanserin, compared with placebo, has been associated with improvement in sexual desire.ΓÇ¥

What is hypoactive sexual desire disorder?

At one time, the definition was as follows: ΓÇ£A deficiency or absence of sexual fantasies and desire for sexual activity.ΓÇ¥ However, in an April 2nd 2014 letter to the FDA from nine groups including the American WomenΓÇÖs Medical Association, the authors pointed out the following: ΓÇ£Hypoactive sexual desire disorder is no longer listed in the DSM-5 (5th edition approved by the American Psychiatric Association in May 2013). Flibanserin, as currently tested, would be approved for a nonexistent condition that will no longer be diagnosed. Rigorous DSM-5 processes were unable to support a distinction between sexual desire and arousal disorders for women, and the new terminology, ΓÇÿfemale sexual interest/arousal disorder,ΓÇÖ offers revised criteria for making a diagnosis.ΓÇ¥

If flibanserin is approved by the FDA in August of 2015, what will the brand name be?

The proposed trade name is Addyi. Ah, the possibilities for TV commercials to rival those old Viagra spots with Bob Dole! Picture couples cavorting amorously, followed by a rushed and mumbled list of side effects, and then an announcer intoning ΓÇ£Ask your doctor if Addyi is right for you.ΓÇ¥

But I digress. Chances are that Addyi wouldnΓÇÖt be the only female medical aphrodisiac on the market for very long. Palatin Technologies is developing a competitor with the generic name bremelanotide. Trials of the drug were discontinued in 2008 because increased blood pressure was a side effect of the original intranasal administration. Then starting in December 2014, Palatin began testing a subcutaneous drug delivery system that apparently has little effect on blood pressure. According to Business Insider, Palatin shares ΓÇ£jumped more than 46% on FridayΓÇ¥, one day after the June 4th flibanserin hearing.

In the meantime, why not try revving up your summer lovinΓÇÖ with some old stand-by aphrodisiacs such as oysters, chili peppers, chocolate, and avocados. You probably canΓÇÖt get your hands on any ground-up rhinoceros horns — but if you could, they might increase your odds of having more fun in bed. At least thatΓÇÖs what the ancient Chinese believed. On a more serious note, Marie Savard M.D. says that the only true aphrodisiac for women is testosterone when levels are low. Yes, females do have testosterone, and it declines as we age. But thatΓÇÖs another story for another time!

Reviewed by Marie Savard, M.D., a former Medical Contributor for ABC News and a frequent keynote speaker around the world, is one of the most trusted voices on women’s health, wellness, and patient empowerment. She is the author of four books, including one that made the Wall Street Journal list of the best health books of 2009: “Ask Dr. Marie: What Women Need to Know about Hormones, Libido, and the Medical Problems No One Talks AboutΓÇ¥, with Sondra Forsyth. Please visit DrSavard.com.