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U.S. regulators broadened the authorized use of a once-a-day medication to manage hypoactive sexual desire disorder (HSDD) in women to cover postmenopausal women up to age 65.

Prior to this week's decision, the medication, flibanserin (Addyi), was exclusively cleared to address low sexual desire in women of reproductive age.

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

The agency had denied approval for the drug on two separate occasions, in 2010 and again in 2013. In both cases, the agency cited issues about safety, efficacy, and an unfavorable risk–benefit profile.

Currently, Addyi is the only FDA-approved oral medication for HSDD, though the FDA cleared bremelanotide (Vyleesi), an injectable used when desired, in 2019.

The founder and CEO of the pharmaceutical company of Addyi praised the FDA’s move to expand the drug’s approval, calling it a “milestone” in advancing and focusing on female sexual health.

Other women’s health experts were supportive for the decision.

“There was nothing for me to recommend because everything was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Securing the FDA approval for this group of women could be significant to address postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told news outlets that the decision was “quite reasonable” given the existing research.

While in favor, the expert was cautious in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the degree of the benefit is not substantial. Does it justify taking a drug daily and not seeing a major effect?”

Understanding Flibanserin, the ‘Female Viagra’?

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

This medication was originally developed as an medication for depression but was found to be lacking during initial trials.

However, scientists observed positive changes in measures of sexual function and shifted focus to the drug’s possible use as a treatment for low libido.

Following initial denials, flibanserin was cleared in 2015 to treat HSDD, following further studies and a significant lobbying effort.

The medication carries a serious safety warning for severe adverse reactions, including a drop in blood pressure and fainting (syncope), when taken alongside alcohol.

Official guidance recommends waiting at least two hours after consuming alcohol before using the drug to minimize the chance of syncope. If a person consumes several drinks on a given day, the label advises skipping the dose entirely.

Claims about the effects of mixing Addyi and alcohol eventually prompted the pharmaceutical company to fund further research investigating the combination. The studies, which were limited in size, showed no increased danger of fainting. But experts had reservations.

“This research aren't very persuasive to me. They are a good start, but they’re not very big and certainly are short-term,” a health research president stated.

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

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

Another doctor echoed confusion about why the expanded indication was limited at 65 years of age.

“I don’t know if that has to do with the complexity of the medication. If you take a list of the dos and don’ts, they are extensive. Now that this has been approved, 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, Addyi could still broaden therapeutic choices for low desire to a different group of females who may benefit.

“I do think it will benefit this demographic better as long as they have no other medical problems,” said an specialist.

But it is not a magic bullet. In fact, the experts consulted universally acknowledged that the women's sexual desire is complex and multifaceted.

So treating HSDD means engaging with everything from relationship dynamics to hormonal changes.

Women after menopause experience a wide variety of changes that can impact libido. Menopausal symptoms include:

• hot flashes
• 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.

“When a patient presents with libido issues, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” she said.

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

She expressed hope 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 consider it as a viable choice.

Androgen therapy is also occasionally 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 personal habits should also be considered. Conversations about sexual desire almost always start with partnership dynamics and closeness.

“I am comfortable prescribing Addyi after discussing it with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Other recommendations for increasing libido include:

• improving sleep hygiene
• engaging in physical activity
• staying active
• using over-the-counter lubricants
• engaging in extended foreplay
• incorporating sexual wellness devices or dilators

“You have to take an comprehensive, holistic strategy to sexual health and menopause in later life,” said an OB-GYN. “That means knowing how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of sexual pleasure.”