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The federal agency expanded its approval of a once-a-day medication to address low libido in women to include postmenopausal women up to the age of sixty-five.

Before the announcement, the pill, Addyi (flibanserin), was only approved to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

Flibanserin was initially cleared by the FDA in 2015, following a lengthy and contentious evaluation period.

Regulators had earlier turned down the drug on two separate occasions, in 2010 and again in 2013. In both cases, the FDA cited issues about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Now, Addyi is the exclusive pill authorized for HSDD, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

The chief executive of the pharmaceutical company of Addyi commended the FDA’s action to expand the drug’s approval, calling it a “landmark event” in advancing and focusing on female sexual health.

Additional OB-GYNs voiced approval for the decision.

“There was nothing for me to prescribe because everything was for women who were menstrual and not menopausal,” said an OB-GYN. “Securing the FDA clearance for this group of women could be very important to address postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told reporters that the approval was “quite reasonable” given the available data.

While in favor, the expert was guarded in her evaluation: “Clinical trials showed statistical significance of the drug over the inactive pill, but the degree of the benefit is not substantial. Does it justify taking a drug daily and not experiencing a dramatic change?”

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

Flibanserin, which is sometimes referred to as “the women's version of Viagra,” has significant differences with the drug from which it gets its informal name.

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

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

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

Addyi carries a serious safety warning for serious adverse reactions, including a drop in blood pressure and fainting (syncope), when combined with alcohol.

Official guidance recommends waiting at least two hours after consuming alcohol before taking the drug to reduce the risk 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 prompted the maker to fund further research examining the combination. The research, which were limited in size, showed no additional risk of syncope. But medical professionals had reservations.

“This research don’t seem very convincing to me. They are a good start, but they’re not very large-scale and certainly aren’t very long,” a public health expert stated.

An OB-GYN suggested that this may have been part of the cause why the drug was not initially cleared for postmenopausal women.

“Patients have experienced side effects like the syncopal episodes and lightheadedness especially in individuals who have had an alcoholic beverage within two hours of taking the pill. 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 complexity of the drug. Reviewing a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been cleared, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Addressing Low Libido After Menopause

Notwithstanding the warnings, Addyi could still broaden therapeutic choices for low desire to a different group of women who may find help.

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

But it is not a quick fix. In fact, the experts interviewed 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 wide variety of symptoms that can impact libido. Menopausal symptoms encompass:

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

As noted by one expert, treating these issues is often a first step toward sexual wellness.

“If somebody came to me with libido issues, my first question is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

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

She expressed hope that the FDA’s recent removal of its “serious” warning on HRT will lead more females to feel less concerned about it and to view it as a viable choice.

Testosterone is also occasionally used without formal approval to address reduced desire in females, although it is not officially approved for it.

But in addition to drugs, doctors say that personal habits should also be considered. Conversations about libido almost always start with relationships and intimacy.

“I would have no problem recommending flibanserin after having a conversation 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 include:

• improving sleep hygiene
• exercising
• staying active
• applying over-the-counter lubricants
• engaging in extended intimate stimulation
• incorporating vibrators or dilators

“You have to take an comprehensive, holistic strategy to sexual health and this life stage in later life,” 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 climax of orgasm.”