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The federal agency broadened the authorized use of a daily pill to manage hypoactive sexual desire disorder (HSDD) in females to cover postmenopausal women up to age 65.

Prior to this week's decision, the medication, flibanserin (Addyi), was only approved to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

Flibanserin was originally authorized by the FDA in two thousand fifteen, following a lengthy and contentious evaluation period.

The agency had denied approval for the drug on two distinct instances, in 2010 and again in 2013. In each instance, the FDA expressed reservations about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Now, Addyi is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in 2019.

The chief executive of the pharmaceutical company of Addyi commended the FDA’s move to broaden the drug’s indication, calling it a “significant step” in advancing and focusing on female sexual health.

Additional OB-GYNs were supportive for the decision.

“There was nothing for me to prescribe because everything was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this group of women could be significant to address women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the approval was “logical” given the available data.

While in favor, the expert was cautious in her evaluation: “Clinical trials showed statistical significance of the drug over the placebo, but the magnitude of the enhancement is not overwhelming. Is it worthwhile taking a drug daily and not seeing a major effect?”

Understanding Addyi, the ‘Women's Desire Pill’?

Flibanserin, which is often called “the women's version of Viagra,” has few similarities with the medication from which it draws its nickname.

This medication was initially researched as an antidepressant but was found to be lacking during early studies.

Nevertheless, researchers noted positive changes in measures of libido and arousal and redirected efforts to the drug’s possible use as a therapy for low libido.

Following initial denials, flibanserin was approved in 2015 to treat HSDD, following additional research and a considerable lobbying effort.

The medication carries a boxed (“black box”) warning for severe side effects, including low blood pressure (hypotension) and loss of consciousness, when combined with alcoholic drinks.

Official guidance recommends waiting at least two hours after consuming alcohol before taking the drug to minimize the chance of syncope. If a person has three or more alcoholic drinks on a single occasion, the label advises not taking the pill entirely.

Assertions about the interactions of combining Addyi and alcohol eventually led the maker to fund further research investigating the combination. The studies, which were small in scale, showed no increased danger of syncope. But experts had reservations.

“This research aren't very convincing to me. They are a good start, but they’re not very big and certainly are short-term,” a health research president stated.

An OB-GYN suggested that this may have been part of the reason why the drug was not initially cleared for postmenopausal women.

“There have been adverse reactions like the syncopal episodes and lightheadedness especially in persons who have had an drink within two hours of taking the pill. When you get more advanced in age, you become more susceptible to effects like that,” she said.

Another doctor echoed confusion about why the broader approval was limited at age 65.

“I don’t know if that has to do with the intricacies of the drug. Reviewing a list of the dos and don’ts, they are extensive. Now that this has been approved, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire After Menopause

Despite these risks, Addyi could still expand treatment options for low desire to a different group of females who may benefit.

“I do think it will serve this demographic better as long as they have no other medical problems,” said an OB-GYN.

But it is not a magic bullet. In fact, the experts consulted universally acknowledged that the women's sexual desire is influenced by many factors.

So addressing HSDD means considering everything from partnership issues to hormonal changes.

Postmenopausal females navigate a broad range of symptoms that can affect libido. Menopausal symptoms include:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• sleep disturbances
• bladder leakage

As noted by one expert, treating these symptoms is often a first step toward improved intimacy.

“When a patient presents with libido issues, my initial inquiry is: How’s your vagina feeling? Are you comfortable?” she said.

The expert suggested both topical estrogen therapy and systemic hormone therapy as options to alleviate the symptoms of menopause, particularly vaginal dryness.

She hopes that the regulatory decision to lift of its “black box” warning on HRT will lead more women to feel less concerned about it and to consider it as a viable choice.

Androgen therapy is also occasionally prescribed off-label to treat low libido in women, although it is not indicated for it.

But in addition to drugs, doctors say that lifestyle should also be factored in. Discussions about sexual desire almost always start with relationships and intimacy.

“I would have no problem prescribing Addyi after discussing it with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said.

Other suggestions for increasing libido are:

• getting more sleep
• engaging in physical activity
• staying active
• using over-the-counter lubricants
• engaging in extended intimate stimulation
• incorporating sexual wellness devices or dilators

“It requires an entire whole body approach to sexuality and this life stage in older age,” said an OB-GYN. “That means understanding how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a peak of sexual pleasure.”