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The Food and Drug Administration (FDA) widened the indication of a daily pill to manage low libido in females to now encompass postmenopausal women up to age 65.

Before the announcement, the medication, flibanserin (Addyi), was solely authorized to address low sexual desire in premenopausal females.

Flibanserin was initially cleared by the FDA in 2015, 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 its safety profile, efficacy, and an concerning balance of risks and benefits.

Now, flibanserin is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an as-needed injectable treatment, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of flibanserin commended the FDA’s decision to broaden the drug’s indication, calling it a “significant step” in advancing and focusing on women's sexual wellness.

Additional specialists in female health voiced approval for the regulatory move.

“Previously, options were limited for me to prescribe because available treatments was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this group of women could be crucial to help postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told reporters that the decision was “quite reasonable” given the clinical evidence.

Although supportive, the expert was cautious in her evaluation: “The studies showed statistical significance of the drug over the inactive pill, but the extent of the enhancement is not overwhelming. Is it worthwhile taking a drug every single day and not seeing a major effect?”

Understanding Flibanserin, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “the women's version of Viagra,” has few similarities with the medication from which it draws its nickname.

The drug was initially researched as an medication for depression but was found to be lacking during early studies.

However, researchers noted improvements in aspects of sexual function and shifted focus to the drug’s potential as a treatment for diminished sexual desire.

Following initial denials, Addyi was approved in 2015 to treat HSDD, following additional research and a major lobbying effort.

Addyi carries a boxed (“black box”) warning for potentially dangerous side effects, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcohol.

Official guidance recommends allowing a two-hour gap after consuming alcohol before taking the drug to minimize the chance of syncope. If a person consumes three or more alcoholic drinks on a given day, the label recommends not taking the pill entirely.

Claims about the interactions of mixing Addyi and alcohol eventually prompted the maker to fund further research examining the combination. The research, which were small in scale, demonstrated no increased danger of fainting. But experts had concerns.

“This research don’t seem very persuasive to me. They are a beginning, but they’re not very large-scale and certainly are short-term,” a public health expert stated.

An gynecologist speculated that this may have been part of the cause why Addyi was not originally approved for older females.

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

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

“I don’t know if that has to do with the intricacies 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 simpler guidance because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

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

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

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

So addressing HSDD means considering everything from partnership issues to hormonal changes.

Postmenopausal females navigate a broad range of symptoms that can affect libido. Menopausal symptoms encompass:

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• insomnia
• bladder leakage

According to one expert, treating these symptoms is often a first step toward sexual wellness.

“If somebody came to me with libido issues, my initial inquiry is: How’s your vagina feeling? 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 vaginal dryness.

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

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

But in addition to drugs, experts say that lifestyle should also be factored in. Conversations about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable prescribing 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.

Additional suggestions for boosting libido include:

• improving sleep hygiene
• engaging in physical activity
• staying active
• using over-the-counter lubricants
• engaging in extended foreplay
• incorporating sexual wellness devices or dilators

“It requires an entire whole body approach to sexual health and this life stage in older age,” said an expert. “That means understanding how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of sexual pleasure.”