U.S. Food and Drug Administration Grants Approval to Flibanserin, a Desire-Boosting Drug for Women After Menopause

The federal agency broadened the authorized use of a daily pill to manage low libido in women to cover postmenopausal women up to age 65.

Prior to this week's decision, the drug, Addyi (flibanserin), was exclusively cleared to address low sexual desire in premenopausal females.

The drug was initially cleared 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 agency expressed reservations about its safety profile, efficacy, and an concerning balance of risks and benefits.

Currently, flibanserin is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an on-demand injection, in 2019.

The founder and CEO of the maker of flibanserin commended the FDA’s decision to expand the drug’s indication, calling it a “landmark event” in understanding and prioritizing female sexual health.

Other OB-GYNs voiced approval for the decision.

“I had few tools for me to recommend because everything was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be significant to address women after menopause who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the approval was “understandable” given the clinical evidence.

Although supportive, the expert was cautious in her assessment: “The studies showed statistical significance of the drug over the inactive pill, but the degree of the benefit is not dramatic. Is it worthwhile taking a drug every single day and not getting bang for your buck?”

Understanding Flibanserin, 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 initially researched as an medication for depression but was found to be lacking during initial trials.

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

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

Addyi carries a serious safety warning for potentially dangerous side effects, including low blood pressure (hypotension) and loss of consciousness, when combined with alcoholic drinks.

The label recommends waiting at least two hours after drinking before taking the drug to minimize the chance of fainting. If a person has three or more alcoholic drinks on a single occasion, the instructions recommends skipping the dose entirely.

Assertions about the interactions of combining Addyi and alcohol eventually led the maker to fund further research examining the interaction. The research, which were small in scale, showed no increased danger of syncope. But medical professionals had concerns.

“These studies don’t seem very convincing 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 cause why Addyi was not initially cleared for older females.

“There have been adverse reactions like the fainting spells and dizziness especially in individuals who have had an drink within two hours of treatment. When you get older, you become more susceptible to things like that,” she said.

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

“I don’t know if that has to do with the complexity of the medication. Reviewing a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been approved, they need to come out with an clearer instructions because it may affect our prescribing,” he said.

Addressing Low Libido After Menopause

Despite these risks, Addyi could still broaden therapeutic choices for low desire to a new population of women who may benefit.

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

But it is not a simple solution. In fact, the specialists interviewed all agreed that the female libido is influenced by many factors.

So addressing low desire means engaging with everything from partnership issues to hormonal changes.

Postmenopausal females navigate a broad range of changes that can impact sexual desire. Symptoms of menopause encompass:

• hot flashes
• lack of natural lubrication
• pain during intercourse
• insomnia
• bladder leakage

According to one expert, managing these issues is often a initial approach toward sexual wellness.

“If somebody came to me with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

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

Testosterone is also occasionally used without formal approval to address low libido in women, although it is not officially approved for it.

But besides medication, experts say that lifestyle should also be considered. Discussions about sexual desire almost always begin by focusing on relationships and intimacy.

“I am comfortable prescribing flibanserin 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.

Other suggestions for increasing libido include:

• improving sleep hygiene
• engaging in physical activity
• staying active
• using over-the-counter lubricants
• practicing extended foreplay
• using vibrators or dilators

“It requires an comprehensive, holistic strategy to sexual health and this life stage in older age,” said an expert. “That means 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 peak of orgasm.”