🔗 Share this article

U.S. regulators widened the indication of a once-a-day medication to treat low libido in women to cover postmenopausal women up to age 65.

Before the announcement, the drug, Addyi (flibanserin), was exclusively cleared to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

Flibanserin was first approved by the FDA in two thousand fifteen, following a lengthy and contentious evaluation period.

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

Today, Addyi is the exclusive pill authorized for HSDD, though the FDA approved bremelanotide (Vyleesi), an injectable used when desired, in two thousand nineteen.

The chief executive of the maker of Addyi praised the FDA’s decision to expand the drug’s indication, calling it a “milestone” in understanding and prioritizing women's sexual wellness.

Additional OB-GYNs expressed support for the decision.

“Previously, options were limited for me to prescribe because everything was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be very important to help women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told reporters that the decision was “logical” given the clinical evidence.

Although supportive, the expert was measured in her assessment: “Clinical trials showed statistical significance of the drug over the placebo, but the extent of the enhancement is not substantial. Is it worthwhile taking a drug daily and not seeing a major effect?”

What is Addyi, the ‘Female Viagra’?

Flibanserin, which is sometimes referred to as “female Viagra,” has little in common with the drug from which it gets its informal name.

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

However, scientists observed positive changes in aspects of sexual function and shifted focus 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 considerable lobbying effort.

Addyi carries a serious safety warning for serious adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when combined with alcohol.

The label recommends allowing a two-hour gap after drinking before taking the drug to minimize the risk of fainting. If a person consumes three or more alcoholic drinks on a single occasion, the label advises skipping the dose entirely.

Assertions about the interactions of combining the drug with drinking eventually prompted the maker to fund further research examining the combination. The studies, which were small in scale, demonstrated no additional risk of syncope. But medical professionals had reservations.

“These studies don’t seem very convincing 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 Addyi was not originally approved for postmenopausal women.

“Patients have experienced side effects like the fainting spells and dizziness especially in persons 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 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 Low Libido in Postmenopausal Women

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

“I do think it will serve this demographic better as long as they have no other health issues,” said an specialist.

But it is not a magic bullet. In fact, the experts consulted all agreed that the female libido is complex and multifaceted.

So treating HSDD means considering everything from relationship dynamics to shifts in hormone levels.

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

• hot flashes
• vaginal dryness
• pain during intercourse
• sleep disturbances
• urinary incontinence

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

“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 recommended both topical estrogen therapy and hormone replacement therapy (HRT) as treatments to treat the effects of menopause, particularly dryness.

She expressed hope that the regulatory decision to lift of its “black box” warning on hormone therapy will lead more females to feel less apprehensive about it and to consider it as a viable choice.

Testosterone is also occasionally prescribed off-label to address reduced desire in women, although it is not indicated 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 relationships and intimacy.

“I am comfortable prescribing Addyi 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.

Additional recommendations for boosting sexual desire are:

• improving sleep hygiene
• exercising
• staying active
• applying over-the-counter lubricants
• engaging in extended foreplay
• incorporating sexual wellness devices or vaginal dilators

“You have to take an entire whole body approach to sexuality and this life stage in older age,” said an expert. “This involves understanding how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of orgasm.”