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The federal agency expanded its approval of a daily pill to address hypoactive sexual desire disorder (HSDD) in women to include women after menopause up to the age of sixty-five.

Prior to the recent news, the medication, flibanserin (Addyi), was solely authorized to treat low sexual desire in women of reproductive age.

The drug was first approved by the FDA in two thousand fifteen, following a protracted and controversial review process.

The agency had denied approval for the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA raised concerns about its safety profile, efficacy, and an concerning balance of risks and benefits.

Now, flibanserin is the sole oral drug cleared by the FDA for HSDD, though the FDA approved bremelanotide (Vyleesi), an injectable used when desired, in 2019.

The chief executive of the maker of flibanserin praised the FDA’s action to broaden the drug’s indication, calling it a “landmark event” in understanding and prioritizing female sexual health.

Additional specialists in female health were supportive for the regulatory move.

“I had few tools for me to prescribe because everything was for women who were menstrual and not menopausal,” said an OB-GYN. “Securing the FDA clearance for this patient population could be very important to address postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told reporters that the approval was “logical” given the existing research.

Although supportive, the expert was cautious in her evaluation: “Clinical trials showed statistical significance of the drug over the placebo, but the magnitude of the benefit is not substantial. Is it worthwhile taking a drug every single day and not seeing a major effect?”

What is Addyi, the ‘Female Viagra’?

Flibanserin, which is sometimes referred to as “female Viagra,” has little in common with the drug from which it draws its nickname.

This medication was first created as an antidepressant but was considered unsuccessful during early studies.

Nevertheless, scientists noted positive changes in measures of libido and arousal and shifted focus to the drug’s potential as a therapy for low libido.

After two rejections, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant advocacy campaign.

Addyi carries a serious safety warning for serious side effects, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcoholic drinks.

Official guidance advises allowing a two-hour gap after consuming alcohol before using the drug to reduce the risk of syncope. If a person consumes several drinks on a single occasion, the instructions advises skipping the dose entirely.

Claims about the interactions of mixing Addyi and alcohol eventually prompted the maker to fund further research examining the combination. The studies, which were small in scale, showed no additional risk of fainting. But medical professionals had reservations.

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

An OB-GYN speculated that this may have been part of the cause why the drug was not originally approved for older females.

“There have been side effects like the fainting spells and dizziness especially in individuals who have had an alcoholic beverage within two hours of treatment. When you get older, you become more sensitive to things like that,” she said.

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

“I don’t know if that has to do with the complexity of the medication. If you take a list of the dos and don’ts, they are extensive. Now that this has been cleared, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire After Menopause

Notwithstanding the warnings, Addyi could still expand therapeutic choices for low desire to a new population 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 specialist.

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

So treating low desire means engaging with everything from relationship dynamics to shifts in hormone levels.

Women after menopause navigate a wide variety of changes that can affect libido. Symptoms of menopause include:

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

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

“When a patient presents with libido issues, my first question is: How’s your vagina feeling? Is intercourse painful?” she said.

The expert recommended both vaginal estrogen 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 hormone therapy will lead more women to feel less concerned about it and to view it as a viable choice.

Androgen therapy is also occasionally used without formal approval to treat reduced desire in females, although it is not indicated for it.

But in addition to drugs, doctors say that personal habits should also be factored in. Discussions about libido almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem prescribing flibanserin 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.

Additional suggestions for boosting libido include:

• getting more sleep
• exercising
• maintaining an active lifestyle
• using over-the-counter lubricants
• practicing extended intimate stimulation
• using sexual wellness devices or vaginal dilators

“It requires an comprehensive, holistic strategy to sexual health and this life stage in later life,” said an expert. “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 excited, and ultimately to have a climax of sexual pleasure.”