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U.S. regulators expanded its approval of a oral treatment to treat hypoactive sexual desire disorder (HSDD) in females to include women after menopause up to the age of sixty-five.

Before this week's decision, the pill, Addyi (flibanserin), was exclusively cleared to address low sexual desire in women of reproductive age.

This medication was first approved by the FDA in 2015, following a lengthy and contentious review process.

The FDA previously rejected the drug on two separate occasions, in 2010 and 2013. In both cases, the agency cited issues about safety, effectiveness, and an concerning balance of risks and benefits.

Currently, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an as-needed injectable treatment, in two thousand nineteen.

The chief executive of the maker of Addyi applauded the FDA’s action to expand the drug’s approval, calling it a “significant step” in advancing and focusing on women's sexual wellness.

Other specialists in female health voiced approval for the decision.

“I had few tools for me to recommend because available treatments was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Getting the FDA approval for this patient population could be significant to help postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told news outlets that the decision was “understandable” given the existing research.

While in favor, the expert was cautious in her assessment: “The studies showed statistical significance of the drug over the inactive pill, but the magnitude of the improvement is not substantial. Does it justify taking a drug daily and not seeing a major effect?”

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

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

The drug was first created as an medication for depression but was found to be lacking during initial trials.

Nevertheless, scientists observed positive changes in measures of sexual function and redirected efforts to the drug’s possible use as a treatment for diminished sexual desire.

After two rejections, flibanserin was cleared in 2015 to treat HSDD, following further studies and a considerable lobbying effort.

Addyi carries a serious safety warning for serious adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when combined with alcoholic drinks.

The label recommends waiting at least two hours after drinking before taking Addyi to reduce the risk of fainting. If a person consumes several drinks on a given day, the instructions advises not taking the pill entirely.

Claims about the interactions of combining Addyi and alcohol eventually prompted the maker to fund further research investigating the combination. The research, which were small in scale, demonstrated no additional risk of fainting. But experts had concerns.

“This research don’t seem very persuasive to me. They are a beginning, but they’re not very big and certainly aren’t very long,” a health research president stated.

An OB-GYN speculated that this may have been part of the reason why the drug was not originally approved 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 susceptible to effects like that,” she said.

Another doctor expressed confusion about why the expanded indication was capped at age 65.

“I don’t know if that has to do with the intricacies of the drug. If you take 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 in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still broaden treatment options for low desire to a new population of women who may benefit.

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

But it is not a quick fix. In fact, the specialists interviewed universally acknowledged that the women's sexual desire is influenced by many factors.

So addressing low desire means considering everything from partnership issues to shifts in hormone levels.

Women after menopause experience a broad range of changes that can affect libido. Symptoms of menopause include:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• sleep disturbances
• bladder leakage

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

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

The expert suggested both vaginal estrogen and hormone replacement therapy (HRT) as options to treat the effects of menopause, particularly vaginal dryness.

She hopes that the FDA’s recent removal of its “serious” warning on hormone therapy will lead more females to feel less concerned about it and to consider it as a viable choice.

Androgen therapy is also occasionally prescribed off-label to treat reduced desire in women, although it is not officially approved for it.

But in addition to drugs, doctors say that personal habits should also be considered. Discussions about sexual desire almost always begin by focusing on relationships and intimacy.

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

Other suggestions for increasing sexual desire are:

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

“You have to take an comprehensive, holistic strategy 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 orgasm.”