The first prescription drug aimed at restoring a woman’s sexual desire has cleared regulatory approval. But is the little pink pill for you? If you’re merely looking for something to put you in the mood, the answer is no.
The drug, which is called flibanserin and will be sold under the brand name Addyi®, is to be used only to treat a specific condition in premenopausal women called hypoactive sexual desire disorder (HSDD). Women with this diagnosis have experienced a loss or decrease in sexual desire.
The loss causes marked distress or interpersonal difficulty and is not due to another medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug.
People should not confuse the drug with an aphrodisiac, says Holly L. Thacker, MD, director of Cleveland Clinic’s Center for Specialized Women’s Health
“It’s not a drug to increase libido,” Dr. Thacker says. “Flibanserin treats hypoactive sexual desire disorder in premenopausal women. The drug restores sexual desire back to the woman’s previous baseline, so it’s not an aphrodisiac.”
The Food and Drug Administration (FDA) on Tuesday gave its approval to the drug. The drug is thought to work by changing the balance of certain brain neurotransmitters like dopamine and serotonin, although the exact mechanisms are unknown, the FDA says.
A new option
“The FDA approval provides an additional, helpful option for women across the country who experience sexual dysfunction,” Dr. Thacker says.
In clinical trials of flibanserin, women experienced two to three “satisfying sexual events” per month before joining the study. Those who took flibanserin reported an average of 0.5 to 1.0 additional satisfying sexual events per month, compared to women given a placebo, according to an FDA analysis.
“The medication has been studied in 11,000 women and it does improve sexual function in women who have certain sexual problems,” Dr. Thacker says. “It doesn’t treat all sexual dysfunction, it won’t help all women with sexual problems, but it will have a role in the therapy.”
Concern about side effects
The drug, which you must take every day, can cause severe low blood pressure and loss of consciousness, the FDA says. These risks are increased and more severe when patients drink alcohol or take the drug with certain medicines that interfere with the breakdown of flibanserin in the body.
“Because of a potentially serious interaction with alcohol, treatment with Addyi® will only be available through certified health care professionals and certified pharmacies,” FDA spokeswoman Janet Woodcock, MD, said in a news release. “Patients and prescribers should fully understand the risks associated with the use of Addyi® before considering treatment.”
The FDA has rejected flibanserin twice since 2010, citing concerns over its side effects. Patients and their doctors will need to weigh the benefits against the risks, Dr. Thacker says.
“Just like with any medication – adult women, in conjunction with their physician, can make an informed decision about whether this is an appropriate therapy for them,” Dr. Thacker says.
In June, an FDA advisory panel voted to recommend the drug on the condition that the manufacturer take specified steps to limit the pill’s risks.
“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” Dr. Woodcock said in the news release.
More information
Read Dr. Thacker’s blog on Health Essentials
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