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U.S. regulators expanded its approval of a daily pill to manage low libido in females to cover postmenopausal women up to the age of sixty-five.

Prior to this week's decision, the pill, Addyi (flibanserin), was exclusively cleared to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

This medication was originally authorized by the FDA in two thousand fifteen, following a lengthy and contentious review process.

The agency had denied approval for the drug on two separate occasions, in 2010 and again in 2013. In each instance, the FDA cited issues about safety, efficacy, and an unfavorable risk–benefit profile.

Currently, flibanserin is the sole oral drug cleared by the FDA for HSDD, though the FDA approved bremelanotide (Vyleesi), an as-needed injectable treatment, in 2019.

The founder and CEO of the pharmaceutical company of flibanserin applauded the FDA’s decision to broaden the drug’s indication, calling it a “significant step” in understanding and prioritizing female sexual health.

Other women’s health experts voiced approval for the decision.

“There was nothing for me to recommend 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 postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the decision was “understandable” given the clinical evidence.

Although supportive, the expert was guarded in her assessment: “The studies showed statistical significance of the drug over the inactive pill, but the extent of the benefit is not overwhelming. Does it justify taking a drug every single day and not seeing a major effect?”

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

Flibanserin, which is sometimes referred to as “female Viagra,” has few similarities with the medication from which it gets its informal name.

This medication was first created as an antidepressant but was considered unsuccessful during initial trials.

Nevertheless, researchers noted positive changes in measures of sexual function and shifted focus to the drug’s potential as a therapy for diminished sexual desire.

After two rejections, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a significant advocacy campaign.

Addyi carries a boxed (“black box”) warning for potentially dangerous adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcoholic drinks.

Official guidance advises allowing a two-hour gap after consuming alcohol before taking Addyi to minimize the risk of syncope. If a person has three or more alcoholic drinks on a single occasion, the label recommends skipping the dose entirely.

Assertions about the interactions of mixing the drug with drinking eventually led the maker to fund additional studies investigating the interaction. The studies, which were limited in size, demonstrated no additional risk of syncope. But medical professionals had reservations.

“These studies aren't very persuasive to me. They are a beginning, but they’re not very big and certainly are short-term,” a public health expert stated.

An OB-GYN suggested that this may have been part of the cause why the drug was not initially cleared for postmenopausal women.

“Patients have experienced adverse reactions like the syncopal episodes and dizziness especially in individuals who have had an drink within two hours of taking the pill. When you get older, you become more susceptible to effects like that,” she said.

Another doctor expressed uncertainty about why the expanded indication was limited at age 65.

“I don’t know if that has to do with the intricacies of the drug. Reviewing 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 After Menopause

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

“I do think it will benefit this population better as long as they have no other medical problems,” said an OB-GYN.

But it is not a simple solution. In fact, the experts interviewed universally acknowledged that the women's sexual desire is influenced by many factors.

So addressing HSDD means engaging with everything from relationship dynamics to hormonal changes.

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

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• insomnia
• bladder leakage

According to one expert, treating these issues is often a first step 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 topical estrogen therapy and hormone replacement therapy (HRT) as options to alleviate the effects of menopause, particularly dryness.

She expressed hope that the FDA’s recent removal of its “black box” warning on hormone therapy will lead more females to feel less concerned about it and to view it as a treatment option.

Androgen therapy is also occasionally 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 lifestyle should also be considered. Conversations about libido almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem recommending flibanserin after having a conversation with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Other recommendations for increasing libido are:

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

“It requires an entire whole body approach to sexual health and menopause in older age,” said an OB-GYN. “This involves understanding 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.”