FDA Clears Flibanserin, a Desire-Boosting Treatment for Women After Menopause

The Food and Drug Administration (FDA) expanded its approval of a daily pill to treat hypoactive sexual desire disorder (HSDD) in women to now encompass women after menopause up to 65 years old.

Prior to the recent news, the medication, flibanserin (Addyi), was exclusively cleared to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

The drug was originally authorized by the FDA in two thousand fifteen, following a long and debated evaluation period.

The agency had denied approval for the drug on two separate occasions, in 2010 and again in 2013. In both cases, the FDA expressed reservations about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Now, flibanserin is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in 2019.

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

Other women’s health experts expressed support for the regulatory move.

“There was nothing for me to prescribe because everything was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this patient population could be very important to help postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

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

Although supportive, the expert was measured in her evaluation: “The studies showed a meaningful difference of the drug over the placebo, 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 ‘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 considered unsuccessful during initial trials.

However, researchers noted improvements in measures of sexual function and shifted focus to the drug’s potential as a treatment for low libido.

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

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

The label recommends waiting at least two hours after consuming alcohol before taking the drug to minimize the risk of fainting. If a person consumes several drinks on a given day, the label advises not taking the pill entirely.

Claims about the interactions of combining the drug with drinking eventually prompted the pharmaceutical company to fund additional studies examining the combination. The research, which were small in scale, demonstrated no increased danger of syncope. But medical professionals had concerns.

“These studies don’t seem very persuasive to me. They are a good start, 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 postmenopausal women.

“There have been adverse reactions like the fainting spells and dizziness especially in persons who have had an drink within two hours of treatment. When you get more advanced in age, you become more sensitive to effects like that,” she said.

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

“I don’t know if that has to do with the intricacies of the drug. If you take a list of the dos and don’ts, 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 prescribing,” he said.

Treating Low Libido in Postmenopausal Women

Despite these risks, Addyi could still expand treatment options for HSDD to a different group of females who may benefit.

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

But it is not a quick fix. In fact, the specialists consulted all agreed that the women's sexual desire is influenced by many factors.

So addressing HSDD means considering everything from relationship dynamics to hormonal changes.

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

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• sleep disturbances
• bladder leakage

According to one expert, managing these symptoms is often a initial approach toward sexual wellness.

“When a patient presents with concerns about desire, my first question is: How’s your vagina feeling? Is intercourse painful?” she said.

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

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

Testosterone is also sometimes used without formal approval to treat low libido in women, although it is not indicated for it.

But besides medication, experts say that lifestyle should also be factored in. Discussions about libido almost always begin by focusing on relationships and intimacy.

“I would have no problem recommending Addyi after having a conversation with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Other suggestions for increasing libido include:

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

“You have to take an entire whole body approach to sexual health and this life stage in older age,” said an OB-GYN. “This involves knowing how your body works, your anatomy, 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 sexual pleasure.”