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The federal agency broadened the authorized use of a daily pill to address hypoactive sexual desire disorder (HSDD) in females to now encompass women after menopause up to age 65.

Prior to the recent news, the drug, flibanserin (Addyi), was only approved to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

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

The agency had denied approval for the drug on two separate occasions, in 2010 and 2013. In both cases, the agency expressed reservations about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Now, Addyi is the exclusive pill authorized for HSDD, though the FDA approved bremelanotide (Vyleesi), an injectable used when desired, in 2019.

The founder and CEO of the maker of flibanserin commended the FDA’s action to broaden the drug’s approval, calling it a “milestone” in understanding and prioritizing women's sexual wellness.

Additional 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 premenopausal and not postmenopausal,” said an OB-GYN. “Securing the FDA clearance for this patient population could be significant to help women after menopause 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 approval was “logical” given the clinical evidence.

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

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

Addyi, which is sometimes referred to as “female Viagra,” has significant differences with the drug from which it draws its nickname.

This medication was originally developed as an antidepressant but was considered unsuccessful during early studies.

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

After two rejections, Addyi was approved 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 fainting (syncope), when combined with alcohol.

The label recommends waiting at least two hours after drinking before taking Addyi to minimize the risk of fainting. If a person consumes three or more alcoholic drinks on a single occasion, the instructions advises not taking the pill entirely.

Assertions about the effects of mixing Addyi and alcohol eventually led the pharmaceutical company to fund additional studies examining the combination. The research, which were small in scale, showed no increased danger of syncope. But experts had reservations.

“This research aren't very persuasive to me. They are a beginning, but they’re not very large-scale 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 initially cleared for older females.

“Patients have experienced adverse reactions like the syncopal episodes and lightheadedness especially in individuals who have had an alcoholic beverage within two hours of treatment. When you get more advanced in age, you become more sensitive to things like that,” she said.

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

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

Addressing Diminished Sexual Desire in Postmenopausal Women

Despite these risks, flibanserin could still expand therapeutic choices for HSDD to a different group of women who may benefit.

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

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

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

Women after menopause navigate a broad range of symptoms that can impact sexual desire. Menopausal symptoms include:

• hot flashes
• lack of natural lubrication
• pain during intercourse
• insomnia
• urinary incontinence

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

“When a patient presents with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

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

She expressed hope 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.

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

But in addition to drugs, experts say that personal habits should also be factored in. Discussions about libido almost always begin by focusing on relationships and intimacy.

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

Additional recommendations for increasing sexual desire include:

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

“It requires an entire whole body approach to sexuality and this life stage in later life,” said an expert. “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.”