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U.S. regulators widened the indication of a oral treatment to treat low libido in females to include women after menopause up to 65 years old.

Prior to the recent news, the drug, Addyi (flibanserin), was exclusively cleared to address low sexual desire in premenopausal females.

Flibanserin was first approved by the FDA in 2015, following a long and debated evaluation period.

Regulators had earlier turned down the drug on two separate occasions, in 2010 and 2013. In both cases, the FDA cited issues about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Now, flibanserin is the sole oral drug cleared by the FDA 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 flibanserin applauded the FDA’s action to broaden the drug’s approval, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Other women’s health experts expressed support for the regulatory move.

“I had few tools for me to prescribe because everything was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this group of women could be very important to address women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told reporters that the decision was “logical” given the available data.

Although supportive, the expert was cautious in her assessment: “Clinical trials showed a meaningful difference of the drug over the placebo, but the magnitude of the improvement is not dramatic. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”

What is Addyi, the ‘Women's Desire Pill’?

Addyi, which is sometimes referred to as “the women's version of Viagra,” has significant differences with the drug from which it draws its nickname.

This medication was initially researched as an medication for depression but was considered unsuccessful during initial trials.

Nevertheless, researchers observed 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, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a considerable advocacy campaign.

Addyi carries a serious safety warning for potentially dangerous side effects, including a drop in blood pressure and loss of consciousness, when combined with alcohol.

The label recommends allowing a two-hour gap after drinking before taking Addyi to reduce the risk of syncope. If a person has three or more alcoholic drinks on a given day, the instructions advises not taking the pill entirely.

Claims about the effects of mixing the drug with drinking eventually led the pharmaceutical company to fund further research examining the combination. The research, which were limited in size, demonstrated no increased danger of syncope. But experts had reservations.

“This research don’t seem very persuasive to me. They are a beginning, but they’re not very large-scale and certainly are short-term,” a health research president stated.

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

“There have been side effects like the fainting spells and dizziness especially in individuals who have had an drink within two hours of taking the pill. When you get more advanced in age, you become more sensitive to effects like that,” she said.

Another doctor expressed uncertainty about why the broader approval was limited at 65 years of age.

“I don’t know if that has to do with the intricacies of the medication. If you take 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 Low Libido After Menopause

Despite these risks, Addyi could still broaden therapeutic choices for HSDD to a new population of females who may benefit.

“I believe it will benefit this population better as long as they have no other medical problems,” said an specialist.

But it is not a quick fix. In fact, the experts consulted universally acknowledged that the female libido is complex and multifaceted.

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

Postmenopausal females navigate a broad range of symptoms that can impact libido. Menopausal symptoms encompass:

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• insomnia
• bladder leakage

According to one expert, treating these issues is often a initial approach toward sexual wellness.

“If somebody came to me with libido issues, my first question is: How’s your vagina feeling? Is intercourse painful?” she said.

The expert recommended both vaginal estrogen and hormone replacement therapy (HRT) as treatments 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 females to feel less concerned about it and to consider it as a treatment option.

Testosterone is also occasionally used without formal approval to address low libido in women, although it is not officially approved for it.

But in addition to drugs, doctors say that personal habits should also be factored in. Discussions about libido almost always start with relationships and intimacy.

“I am comfortable prescribing flibanserin after having a conversation with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Other suggestions for boosting libido include:

• getting more sleep
• engaging in physical activity
• staying active
• applying over-the-counter personal lubricants
• practicing extended foreplay
• incorporating vibrators or vaginal dilators

“It requires an comprehensive, holistic strategy to sexuality and this life stage in later life,” said an expert. “This involves knowing how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of orgasm.”