🔗 Share this article

The federal agency expanded its approval of a daily pill to treat hypoactive sexual desire disorder (HSDD) in women to cover women after menopause up to age 65.

Prior to the recent news, the drug, flibanserin (Addyi), was only approved to treat low sexual desire in women of reproductive age.

This medication was originally authorized by the FDA in 2015, following a lengthy and contentious evaluation period.

The FDA previously rejected the drug on two distinct instances, in 2010 and again in 2013. In each instance, the agency cited issues about safety, efficacy, and an unfavorable risk–benefit profile.

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

The chief executive of the maker of flibanserin applauded the FDA’s action 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 regulatory move.

“There was nothing for me to prescribe because everything was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Getting the FDA clearance for this patient population could be significant to address postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told reporters that the approval was “logical” given the available data.

Although supportive, the expert was cautious in her evaluation: “The studies showed a meaningful difference of the drug over the inactive pill, but the degree of the benefit is not substantial. Does it justify taking a drug every single day and not experiencing a dramatic change?”

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

Addyi, which is often called “female Viagra,” has little in common with the medication from which it draws its nickname.

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

However, scientists noted positive changes in aspects of sexual function and shifted focus to the drug’s potential as a therapy for low libido.

After two rejections, Addyi was approved in 2015 to treat HSDD, following further studies and a considerable advocacy campaign.

Addyi carries a boxed (“black box”) warning for potentially dangerous side effects, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcoholic drinks.

The label advises allowing a two-hour gap after consuming alcohol before taking Addyi to reduce the risk of fainting. If a person has three or more alcoholic drinks on a single occasion, the label recommends not taking the pill entirely.

Claims about the interactions of mixing the drug with drinking eventually prompted the pharmaceutical company to fund further research examining the combination. The studies, which were limited in size, showed no additional risk of syncope. But experts had concerns.

“This research don’t seem very persuasive to me. They are a beginning, but they’re not very big 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 originally approved for older females.

“Patients have experienced side effects like the fainting spells and lightheadedness especially in individuals who have had an alcoholic beverage within two hours of treatment. When you get older, you become more sensitive to effects like that,” she said.

Another doctor expressed confusion about why the broader approval was limited at 65 years of age.

“I don’t know if that has to do with the intricacies of the drug. Reviewing a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been approved, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said.

Addressing Low Libido After Menopause

Despite these risks, flibanserin could still expand therapeutic choices for HSDD to a different group of females who may benefit.

“I believe it will serve this demographic better as long as they have no other health issues,” said an OB-GYN.

But it is not a simple solution. In fact, the specialists interviewed universally acknowledged that the female libido is complex and multifaceted.

So addressing low desire means engaging with everything from relationship dynamics to hormonal changes.

Postmenopausal females experience a broad range of symptoms that can impact sexual desire. Menopausal symptoms encompass:

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

As noted by one expert, managing these issues is often a initial approach toward sexual wellness.

“If somebody came to me with concerns about desire, my initial inquiry 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 treat the effects of menopause, particularly vaginal dryness.

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

Androgen therapy is also sometimes used without formal approval to address low libido in women, although it is not indicated for it.

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

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

Additional suggestions for boosting sexual desire are:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter lubricants
• engaging in extended intimate stimulation
• using vibrators or dilators

“It requires an comprehensive, holistic strategy to sexual health and this life stage in older age,” said an OB-GYN. “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 excited, and ultimately to have a climax of orgasm.”