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U.S. regulators expanded its approval of a daily pill to manage hypoactive sexual desire disorder (HSDD) in females to now encompass postmenopausal women up to the age of sixty-five.

Prior to this week's decision, the pill, flibanserin (Addyi), was solely authorized to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

Flibanserin was first approved by the FDA in 2015, following a protracted and controversial regulatory scrutiny.

The FDA previously rejected the drug on two separate occasions, in 2010 and 2013. In both cases, the agency cited issues about safety, effectiveness, and an unfavorable risk–benefit profile.

Currently, flibanserin is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an on-demand injection, in two thousand nineteen.

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

Other women’s health experts expressed support for the decision.

“I had few tools for me to prescribe because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this group of women could be very important to help postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told news outlets that the approval was “quite reasonable” given the available data.

While in favor, the expert was measured in her assessment: “Clinical trials showed statistical significance of the drug over the inactive pill, but the magnitude of the enhancement is not substantial. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?”

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

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

The drug was initially researched as an medication for depression but was deemed ineffective during initial trials.

Nevertheless, researchers noted improvements in aspects of libido and arousal and redirected efforts to the drug’s potential as a therapy for low libido.

After two rejections, flibanserin was cleared in 2015 to treat HSDD, following further studies and a significant lobbying effort.

The medication carries a boxed (“black box”) warning for severe adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcohol.

The label advises waiting at least two hours after drinking before using the drug to reduce the chance of syncope. If a person consumes several drinks on a single occasion, the instructions recommends not taking the pill entirely.

Claims about the effects of mixing Addyi and alcohol eventually led the pharmaceutical company to fund additional studies investigating the interaction. The studies, which were small in scale, demonstrated no additional risk of fainting. But experts had reservations.

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

An OB-GYN suggested that this may have been part of the reason why Addyi was not originally approved for older females.

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

Another doctor echoed uncertainty about why the broader approval was capped at 65 years of age.

“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 easier information sheet because it may affect our prescribing,” he said.

Treating Low Libido in Postmenopausal Women

Notwithstanding the warnings, Addyi could still broaden treatment options for HSDD to a new population 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 specialists consulted universally acknowledged that the female libido is influenced by many factors.

So treating HSDD 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:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• sleep disturbances
• urinary incontinence

As noted by one expert, managing 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? Are you comfortable?” she said.

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

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

Androgen therapy is also sometimes prescribed off-label to address low libido in females, 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 would have no problem 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.

Other suggestions for increasing sexual desire are:

• getting more sleep
• exercising
• staying active
• using over-the-counter personal lubricants
• practicing extended foreplay
• using vibrators or vaginal dilators

“It requires an comprehensive, holistic strategy to sexuality and this life stage in older age,” said an OB-GYN. “That means knowing how your body works, your physiology, 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.”