Women who have similar libido issues have been excluded from the game – until now. Addyi, or flibanserin, is marketed as "the first of her kind" by its creator, Sprout Pharmaceuticals. An erection obviously isn't the problem for women, but Hypoactive Sexual Desire Disorder (HSDD), the disorder for which Addyi is indicated, might be. HSDD is classified in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) under the category of Female Sexual Interest/Arousal Disorder.
“HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. HSDD is acquired when it develops in a patient who previously had no problems with sexual desire. HSDD is generalized when it occurs regardless of the type of sexual activity, the situation or the sexual partner,” according to the FDA's August 2015 press release about the breakthrough drug.
So why did the FDA reject it in October 2014, and what changed the organization's mind?
Praise for Addyi
Dr. Janet Woodcock, Director of the FDA's Center for Drug Evaluation and Research claimed in the press release: “Today's approval provides women distressed by their low sexual desire with an approved treatment option.”
Sally Greenberg of the National Consumer's League acknowledged the drug's potential impact, “This is the biggest breakthrough for women’s sexual health since the pill.”
Leah Millheiser, director of the Female Sexual Medical Program at Stanford University School of Medicine, supports the diagnosis of HSDD and Addyi for its treatment: "HSDD is a very real problem for women." Millheiser appears to be convinced the disorder is due to a neurotransmitter imbalance, and according to her, “the data [presumably from outcome studies] showed that true responders had six to eight additional sexual events per month” after using Addyi.
Indeed, Addyi seeks to reorder cerebral cortex (brain) chemistry. “Addyi is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist,” the FDA explains. The goal with flibanserin seems to be elevating mood to increase sexual appetite. However, the FDA admittedly doesn't know why the once-daily pill improves sexual dysfunction.
Results on the efficacy of flibanserin come from very few studies. Statistical differences, while considered to be scientifically significant, show minimal appreciable gains for sexual satisfaction and offer non-specific information on the medication's benefits. As with other medications that are thought to alter neurotransmitter functioning, any chemical reactions flibanserin may have are not well understood.
Criticism for Addyi
When the FDA rejected Addyi the first time in October 2014, the outcry from women everywhere was loud and clear, including those in the pharmaceutical industry, women's rights groups and even female Congresswomen. Cindy Whitehead, Sprout's COO, criticized the numerous low testosterone and erectile dysfunction drugs for men – 24 compared with zero for women -- implying the FDA was sexist. Reps. Debbie Wasserman Schultz, Chellie Pingree, Nita Lowey and Louise Slaughter penned a joint letter to FDA Commissioner Margaret Hamburg asking the organization to apply "the same standards of consideration given to the approved drugs for men in your risk/benefit evaluation."
With accusations of sexism becoming widespread, the FDA faced harsh criticism. But in its rush to escape the negative press, did it prove the safety and efficacy of Addyi? Many critics say it did not.
Among the letters to the FDA on behalf of rejecting flibanserin was one from outside the U.S. Sex researchers from the Netherlands and Belgium said, “the drug was based on the mistaken notion that lack of spontaneous sexual desire, absent stimuli, was abnormal.”
Numerous factors can affect sexual desire, none of which can be cured simply with a pill, which is part of the problem. Other medications can reduce desire, such as antidepressants and antiseizure drugs. The Mayo Clinic lists a host of conditions that can cause it, including:
- Arthritis
- Cancer
- Coronary artery disease
- Diabetes
- High blood pressure
- Menopause
- Pregnancy and breastfeeding
- Substance abuse
- Fatigue
- Smoking
Side Effects of Addyi
All drugs have side effects, and Addyi is no different. Sprout's information includes the following potential side effects:
- Sleepiness
- Low blood pressure and fainting
- Dizziness
- Tiredness
- Dry mouth
- Nausea
- Difficulty falling asleep or staying asleep
Cindy Pearson, the executive director of the National Women's Health Network and a self-identified "pro-sex feminist," believes the results are just not enough to conclude exactly how flibanserin will affect women who drink.
Indeed, the fine print in the drug's warning states: “Addyi can cause severely low blood pressure (hypotension) and loss of consciousness (syncope). These risks are increased and more severe when patients drink alcohol or take Addyi with certain medicines (known as moderate or strong CYP3A4 inhibitors) that interfere with the breakdown of Addyi in the body.”
"The FDA should not approve a drug for women with an alcohol interaction study done with men," Pearson told USA TODAY Network.
"In clinical trials testing its effectiveness, flibanserin has either failed or barely passed. Only about 10-12% of women in trials benefitted from taking the drug," Pearson wrote in a Washington Post op-ed, pointing out the drug's poorly proven efficacy.
It is because of this that there are a series of protocol passes to become certified as a practitioner diagnosing HSDD, for the medical professional prescribing Addyi and the pharmacy supplying the medication.
But for many women, the drug may breathe new life into a stagnant relationship, as it did for Amanda Parrish and her husband. The couple seems to have rediscovered sexuality during a trial period with the drug. She noticed a difference in her desire level and her husband's response to it. In light of the data detecting little change in sexual satisfaction or desire when on Addyi, Ms. Parrish is not the only one standing firm in backing the drug. Parrish told Time magazine, “I want to want my husband; it is that simple.”