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U.S. regulators widened the indication of a daily pill to treat hypoactive sexual desire disorder (HSDD) in females to now encompass postmenopausal women up to 65 years old.

Before this week's decision, the medication, Addyi (flibanserin), was exclusively cleared to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

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

Regulators had earlier turned down the drug on two separate occasions, in 2010 and 2013. In each instance, the FDA raised concerns about safety, efficacy, and an concerning balance of risks and benefits.

Today, flibanserin is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an as-needed injectable treatment, in two thousand nineteen.

The founder and CEO of the maker of flibanserin applauded the FDA’s action to expand the drug’s indication, calling it a “milestone” in advancing and focusing on female sexual health.

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

“There was nothing 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 patient population could be significant to address postmenopausal women 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 “quite reasonable” given the existing research.

Although supportive, the expert was measured in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the degree of the benefit is not substantial. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?”

What is Flibanserin, the ‘Women's Desire Pill’?

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

This medication was originally developed as an medication for depression but was considered unsuccessful during initial trials.

However, scientists observed positive changes in aspects of sexual function and shifted focus to the drug’s potential as a treatment for diminished sexual desire.

After two rejections, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a considerable advocacy campaign.

The medication carries a serious safety warning for potentially dangerous side effects, including a drop in blood pressure and loss of consciousness, when combined with alcoholic drinks.

The label recommends allowing a two-hour gap after consuming alcohol before using the drug to minimize the risk of syncope. If a person consumes three or more alcoholic drinks on a single occasion, the label recommends not taking the pill entirely.

Assertions about the interactions of combining Addyi and alcohol eventually led the pharmaceutical company to fund additional studies investigating the combination. The studies, which were small in scale, showed no additional risk of syncope. But experts had concerns.

“These studies don’t seem very convincing to me. They are a good start, 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 the drug was not initially cleared for postmenopausal women.

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

Another doctor echoed confusion about why the expanded indication was capped at age 65.

“It's unclear if that has to do with the intricacies of the medication. If you take a list of the dos and don’ts, they are extensive. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Treating Low Libido in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still broaden treatment options for HSDD to a new population of females who may benefit.

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

But it is not a magic bullet. In fact, the specialists consulted all agreed that the women's sexual desire is influenced by many factors.

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

Women after menopause navigate a broad range of symptoms that can affect libido. Menopausal symptoms include:

• hot flashes
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• urinary incontinence

According to one expert, managing these symptoms is often a initial approach toward improved intimacy.

“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 vaginal dryness.

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

Testosterone is also sometimes used without formal approval to treat low libido in women, although it is not indicated for it.

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

“I would have no problem recommending Addyi after discussing it with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Additional suggestions for increasing libido are:

• improving sleep hygiene
• exercising
• staying active
• applying over-the-counter personal lubricants
• practicing extended foreplay
• using sexual wellness devices or dilators

“It requires an comprehensive, holistic strategy to sexuality and menopause in older age,” said an expert. “This involves knowing how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a peak of orgasm.”