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The federal agency broadened the authorized use of a daily pill to manage hypoactive sexual desire disorder (HSDD) in women to include postmenopausal women up to 65 years old.

Prior to the announcement, the drug, flibanserin (Addyi), was exclusively cleared to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

Flibanserin was initially cleared by the FDA in two thousand fifteen, following a long and debated evaluation period.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In each instance, the agency cited issues about safety, effectiveness, and an unfavorable risk–benefit profile.

Now, flibanserin is the exclusive pill authorized for HSDD, though the FDA cleared Vyleesi (bremelanotide), an on-demand injection, in two thousand nineteen.

The chief executive of the pharmaceutical company of Addyi praised the FDA’s move to broaden the drug’s approval, calling it a “significant step” in understanding and prioritizing female sexual health.

Additional OB-GYNs voiced approval for the regulatory move.

“I had few tools for me to recommend because available treatments was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this patient population could be crucial to help women after menopause 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 “quite reasonable” given the existing research.

While in favor, the expert was guarded in her assessment: “Clinical trials showed a meaningful difference of the drug over the placebo, but the magnitude of the benefit is not substantial. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”

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

Flibanserin, which is sometimes referred to as “female Viagra,” has significant differences with the drug from which it draws its nickname.

The drug was first created as an medication for depression but was deemed ineffective during initial trials.

Nevertheless, researchers noted improvements in measures of libido and arousal and shifted focus to the drug’s possible use as a treatment for diminished sexual desire.

After two rejections, Addyi was cleared in 2015 to treat HSDD, following further studies and a significant 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 taken alongside alcoholic drinks.

Official guidance recommends allowing a two-hour gap after drinking before taking Addyi to minimize the chance of syncope. If a person has three or more alcoholic drinks on a given day, the instructions advises not taking the pill entirely.

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

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

An OB-GYN speculated that this may have been part of the reason why Addyi was not initially cleared for postmenopausal women.

“There have been side effects like the fainting spells and lightheadedness especially in persons who have had an alcoholic beverage within two hours of taking the pill. When you get more advanced in age, you become more sensitive to things like that,” she said.

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

“It's unclear if that has to do with the complexity of the drug. Reviewing a list of the instructions and restrictions, they are extensive. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire After Menopause

Notwithstanding the warnings, Addyi could still broaden therapeutic choices for HSDD to a new population of females 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 magic bullet. In fact, the experts interviewed all agreed that the women's sexual desire is influenced by many factors.

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

Postmenopausal females navigate a wide variety of changes that can impact sexual desire. Menopausal symptoms encompass:

• hot flashes
• vaginal dryness
• pain during intercourse
• insomnia
• 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: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

The expert suggested both topical estrogen therapy and systemic hormone therapy as options to alleviate the symptoms of menopause, particularly dryness.

She hopes that the regulatory decision to lift of its “serious” warning on hormone therapy will lead more females to feel less apprehensive about it and to view it as a treatment option.

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

But besides medication, doctors say that lifestyle should also be considered. Discussions about libido almost always start with partnership dynamics and closeness.

“I am comfortable prescribing flibanserin after having a conversation with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said.

Other recommendations for boosting libido are:

• improving sleep hygiene
• exercising
• staying active
• using over-the-counter personal lubricants
• practicing extended intimate stimulation
• using vibrators or dilators

“It requires an entire whole body approach to sexuality and menopause in older age,” said an OB-GYN. “That means understanding how your body works, your physiology, 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.”