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U.S. regulators expanded its approval of a daily pill to manage low libido in females to now encompass postmenopausal women up to age 65.

Prior to the recent news, the drug, Addyi (flibanserin), was exclusively cleared to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

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

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA raised concerns about safety, efficacy, and an unfavorable risk–benefit profile.

Now, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in 2019.

The founder and CEO of the maker of flibanserin praised the FDA’s move to expand the drug’s indication, calling it a “significant step” in advancing and focusing on women's sexual wellness.

Additional specialists in female health were supportive for the decision.

“There was nothing for me to prescribe because everything was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this patient population could be very important to address women after menopause who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

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

Although supportive, the expert was cautious in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the extent of the enhancement is not overwhelming. Is it worthwhile taking a drug daily and not seeing a major effect?”

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

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

This medication was originally developed as an medication for depression but was deemed ineffective during early studies.

Nevertheless, researchers noted improvements in aspects of sexual function and shifted focus to the drug’s potential as a therapy for low libido.

Following initial denials, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a significant lobbying effort.

Addyi carries a serious safety warning for severe side effects, including a drop in blood pressure and loss of consciousness, when taken alongside alcohol.

The label recommends allowing a two-hour gap after consuming alcohol before taking the drug to minimize the chance of fainting. If a person has several drinks on a given day, the instructions advises not taking the pill entirely.

Claims about the effects of combining Addyi and alcohol eventually prompted the pharmaceutical company to fund additional studies examining the combination. The research, which were limited in size, showed no increased danger of fainting. But experts had reservations.

“These studies aren't very convincing to me. They are a beginning, but they’re not very big and certainly aren’t very long,” a health research president stated.

An gynecologist suggested that this may have been part of the cause why the drug was not originally approved for postmenopausal women.

“Patients have experienced adverse reactions like the fainting spells and lightheadedness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get older, you become more susceptible to effects like that,” she said.

Another doctor echoed confusion about why the expanded indication was limited at 65 years of age.

“It's unclear if that has to do with the complexity of the drug. If you take a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an clearer instructions because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still expand treatment options for HSDD to a different group of women who may find help.

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

But it is not a quick fix. In fact, the experts consulted all agreed that the women's sexual desire is complex and multifaceted.

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

Women after menopause navigate a wide variety of changes that can impact sexual desire. Symptoms of menopause include:

• hot flashes
• vaginal dryness
• discomfort with sex
• insomnia
• urinary incontinence

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

“When a patient presents with concerns about desire, my initial inquiry is: How’s your vagina feeling? Are you comfortable?” she said.

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

She expressed hope that the regulatory decision to lift of its “black box” warning on hormone therapy will lead more women to feel less apprehensive about it and to consider it as a viable choice.

Androgen therapy is also sometimes prescribed off-label to treat reduced desire in females, although it is not indicated for it.

But in addition to drugs, experts say that lifestyle should also be factored in. 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 emotional and relational factors going on,” she said.

Additional recommendations for boosting libido are:

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

“It requires an entire whole body approach to sexuality and menopause in later life,” said an expert. “This involves knowing how your body works, your physiology, 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.”