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U.S. regulators broadened the authorized use of a oral treatment to manage hypoactive sexual desire disorder (HSDD) in women to include postmenopausal women up to age 65.

Prior to the announcement, the pill, Addyi (flibanserin), was solely authorized to treat low sexual desire in premenopausal females.

The drug was originally authorized by the FDA in two thousand fifteen, following a long and debated evaluation period.

The agency had denied approval for the drug on two separate occasions, in 2010 and 2013. In each instance, the FDA cited issues about safety, efficacy, and an concerning balance of risks and benefits.

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

The founder and CEO of the maker of flibanserin applauded the FDA’s decision to broaden the drug’s indication, calling it a “milestone” in advancing and focusing on female sexual health.

Additional OB-GYNs expressed support for the decision.

“I had few tools for me to prescribe because everything was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be significant to address postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told news outlets that the approval was “logical” given the clinical evidence.

Although supportive, the expert was guarded in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the extent of the enhancement is not dramatic. Is it worthwhile taking a drug daily and not getting bang for your buck?”

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

Flibanserin, which is often called “female Viagra,” has few similarities with the medication from which it gets its informal name.

This medication was originally developed as an medication for depression but was found to be lacking during initial trials.

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

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 serious adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcohol.

Official guidance advises waiting at least two hours after consuming alcohol before taking Addyi to reduce the risk of syncope. If a person consumes three or more alcoholic drinks on a given day, the instructions advises skipping the dose entirely.

Claims about the effects of combining Addyi and alcohol eventually prompted the pharmaceutical company to fund further research investigating the combination. The research, which were limited in size, showed no additional risk of syncope. But experts had reservations.

“This research aren't 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 reason why the drug was not originally approved for older females.

“There have been adverse reactions like the fainting spells 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 sensitive to things like that,” she said.

Another doctor expressed uncertainty about why the expanded indication 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 instructions and restrictions, 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.

Addressing Low Libido After Menopause

Despite these risks, Addyi could still broaden treatment options for HSDD to a different group of women who may find help.

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

But it is not a simple solution. In fact, the specialists consulted all agreed that the female libido is influenced by many factors.

So treating HSDD means engaging with everything from partnership issues to shifts in hormone levels.

Women after menopause experience a wide variety of changes that can affect libido. Menopausal symptoms encompass:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• insomnia
• urinary incontinence

As noted by one expert, managing these symptoms is often a initial approach toward improved intimacy.

“If somebody came to me with concerns about desire, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

She expressed hope that the regulatory decision to lift of its “serious” warning on hormone therapy will lead more females to feel less concerned about it and to consider it as a treatment option.

Androgen therapy is also sometimes prescribed off-label to treat low libido in females, although it is not officially approved for it.

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

“I am comfortable prescribing Addyi after having a conversation with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said.

Additional suggestions for increasing sexual desire include:

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

“You have to take an entire whole body approach to sexual health and this life stage in later life,” said an OB-GYN. “This involves knowing how your body works, your anatomy, and your sexual needs — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a peak of orgasm.”