U.S. Food and Drug Administration Approves Addyi, a Libido-Enhancing Drug for Females Beyond Menopause

The Food and Drug Administration (FDA) broadened the authorized use of a oral treatment to treat low libido in women to cover postmenopausal women up to the age of sixty-five.

Before this week's decision, the drug, flibanserin (Addyi), was solely authorized to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

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

The FDA previously rejected the drug on two separate occasions, in 2010 and 2013. In both cases, the FDA expressed reservations about safety, effectiveness, and an concerning balance of risks and benefits.

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

The founder and CEO of the maker of Addyi applauded the FDA’s decision to expand the drug’s approval, calling it a “significant step” in advancing and focusing on female sexual health.

Other OB-GYNs were supportive for the regulatory move.

“There was nothing for me to prescribe because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this group of women could be very important to help postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told news outlets that the decision was “logical” given the available data.

While in favor, the expert was cautious in her assessment: “The studies showed a meaningful difference of the drug over the placebo, but the degree of the enhancement is not overwhelming. Does it justify taking a drug every single day and not getting bang for your buck?”

What is Flibanserin, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “female Viagra,” has significant differences with the medication from which it draws its nickname.

The drug was initially researched as an medication for depression but was deemed ineffective during initial trials.

Nevertheless, scientists noted improvements in measures of libido and arousal and redirected efforts to the drug’s possible use as a therapy for low libido.

After two rejections, Addyi was approved in 2015 to treat HSDD, following further studies and a major 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 alcoholic drinks.

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

Assertions about the effects of combining Addyi and alcohol eventually led the pharmaceutical company to fund additional studies examining the interaction. The research, which were limited in size, demonstrated no additional risk of syncope. But experts had concerns.

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

An OB-GYN speculated that this may have been part of the reason why the drug was not originally approved for older females.

“Patients have experienced adverse reactions 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 susceptible to things like that,” she said.

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

“It's unclear if that has to do with the complexity of the drug. If you take 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 simpler guidance because it may affect our clinical decisions,” he said.

Addressing Low Libido in Postmenopausal Women

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

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

But it is not a quick fix. In fact, the experts consulted universally acknowledged that the female libido is influenced by many factors.

So addressing low desire means engaging with everything from partnership issues to shifts in hormone levels.

Postmenopausal females navigate a broad range of changes that can affect libido. Menopausal symptoms include:

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• urinary incontinence

As noted by one expert, treating 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 alleviate the symptoms of menopause, particularly vaginal dryness.

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

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

But besides medication, doctors say that personal habits should also be factored in. Conversations about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem 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.

Other recommendations for increasing libido include:

• getting more sleep
• exercising
• maintaining an active lifestyle
• using over-the-counter lubricants
• engaging in extended intimate stimulation
• using sexual wellness devices or vaginal dilators

“It requires an comprehensive, holistic strategy to sexuality and this life stage in older age,” said an OB-GYN. “That means understanding how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a peak of sexual pleasure.”