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U.S. regulators broadened the authorized use of a once-a-day medication to treat low libido in women to now encompass women after menopause up to 65 years old.

Prior to the announcement, the drug, flibanserin (Addyi), was exclusively cleared to address low sexual desire in women of reproductive age.

This medication was initially cleared by the FDA in two thousand fifteen, following a long and debated regulatory scrutiny.

The FDA previously rejected the drug on two separate occasions, in 2010 and 2013. In each instance, the FDA cited issues about safety, effectiveness, and an unfavorable risk–benefit profile.

Today, Addyi is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in two thousand nineteen.

The chief executive of the pharmaceutical company of Addyi commended the FDA’s decision to broaden the drug’s approval, calling it a “landmark event” in advancing and focusing on women's sexual wellness.

Additional OB-GYNs were supportive 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 patient population could be crucial 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 “quite reasonable” given the available data.

Although supportive, the expert was cautious in her assessment: “The studies showed a meaningful difference of the drug over the inactive pill, but the magnitude of the improvement is not dramatic. Does it justify taking a drug every single day and not getting bang for your buck?”

What is Addyi, the ‘Female Viagra’?

Flibanserin, which is sometimes referred to as “female Viagra,” has few similarities with the medication from which it gets its informal name.

The drug was initially researched as an medication for depression but was considered unsuccessful during early studies.

Nevertheless, scientists noted improvements in measures of libido and arousal and redirected efforts to the drug’s possible use as a therapy for diminished sexual desire.

Following initial denials, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a major advocacy campaign.

The medication carries a serious safety warning for severe adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when combined with alcohol.

Official guidance recommends waiting at least two hours after drinking before taking Addyi to reduce the chance of syncope. If a person has several drinks on a given day, the label advises not taking the pill entirely.

Assertions about the interactions of mixing Addyi and alcohol eventually led the maker to fund further research examining the combination. The research, which were limited in size, showed no increased danger of fainting. But medical professionals had concerns.

“This research don’t seem very convincing to me. They are a beginning, but they’re not very large-scale and certainly aren’t very long,” a public health expert stated.

An gynecologist speculated that this may have been part of the cause why Addyi was not initially cleared for older females.

“There have been adverse reactions like the syncopal episodes and lightheadedness 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 expanded indication was capped at age 65.

“It's unclear if that has to do with the complexity of the medication. Reviewing a list of the dos and don’ts, it’s really wide-ranging. Now that this has been approved, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire After Menopause

Notwithstanding the warnings, Addyi could still broaden therapeutic choices for HSDD to a new population of females who may find help.

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

But it is not a magic bullet. In fact, the specialists interviewed all agreed that the female libido is complex and multifaceted.

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

Women after menopause experience a broad range of symptoms that can impact libido. Menopausal symptoms encompass:

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• insomnia
• urinary incontinence

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

“When a patient presents with libido issues, my first question is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

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

She expressed hope that the FDA’s recent removal of its “serious” warning on hormone therapy will lead more women to feel less apprehensive about it and to view it as a viable choice.

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

But in addition to drugs, doctors say that lifestyle should also be factored in. Conversations about libido almost always start with partnership dynamics and closeness.

“I would have no problem 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 increasing sexual desire include:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• applying over-the-counter lubricants
• practicing extended foreplay
• incorporating sexual wellness devices or dilators

“It requires an entire whole body approach to sexual health and menopause in older age,” said an expert. “That means knowing how your body works, your anatomy, 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 sexual pleasure.”