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The federal agency expanded its approval of a once-a-day medication to treat low libido in women to include postmenopausal women up to age 65.

Before the announcement, the drug, Addyi (flibanserin), was solely authorized to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

This medication was originally authorized by the FDA in two thousand fifteen, following a lengthy and contentious review process.

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In both cases, the FDA expressed reservations about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Now, Addyi is the only FDA-approved oral medication for HSDD, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in 2019.

The founder and CEO of the maker of Addyi commended the FDA’s move to expand the drug’s indication, calling it a “significant step” in advancing and focusing on women's sexual wellness.

Additional OB-GYNs voiced approval for the decision.

“I had few tools for me to prescribe because available treatments was for women who were premenopausal and not menopausal,” said an OB-GYN. “Securing the FDA approval for this patient population could be very important to help postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

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

While in favor, the expert was cautious in her evaluation: “The studies showed statistical significance of the drug over the inactive pill, but the degree of the improvement is not substantial. Does it justify taking a drug every single day and not experiencing a dramatic change?”

Understanding Addyi, the ‘Women's Desire Pill’?

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

This medication was initially researched as an antidepressant but was found to be lacking during initial trials.

However, scientists observed improvements in measures of sexual function and redirected efforts to the drug’s potential as a treatment for diminished sexual desire.

After two rejections, flibanserin was cleared in 2015 to treat HSDD, following additional research and a significant advocacy campaign.

The medication carries a boxed (“black box”) warning for severe side effects, including low blood pressure (hypotension) and loss of consciousness, when combined with alcoholic drinks.

Official guidance recommends waiting at least two hours after consuming alcohol before taking Addyi to reduce the chance of fainting. If a person consumes several drinks on a single occasion, the label advises not taking the pill entirely.

Claims about the effects of mixing Addyi and alcohol eventually led the pharmaceutical company to fund further research investigating the interaction. The studies, which were small in scale, demonstrated no increased danger of syncope. But medical professionals had concerns.

“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 gynecologist speculated that this may have been part of the reason why Addyi was not initially cleared for postmenopausal women.

“Patients have experienced adverse reactions like the fainting spells and lightheadedness especially in individuals who have had an drink within two hours of taking the pill. When you get older, you become more sensitive to things like that,” she said.

Another doctor expressed uncertainty 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 instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Addressing Low Libido After Menopause

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

“I do think it will serve this demographic better as long as they have no other medical problems,” said an OB-GYN.

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

So addressing HSDD means engaging with everything from partnership issues to hormonal changes.

Women after menopause navigate a broad range of symptoms that can affect libido. Menopausal symptoms encompass:

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

As noted by one expert, treating these issues is often a initial approach toward improved intimacy.

“When a patient presents with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

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

Testosterone is also sometimes prescribed off-label to treat low libido in females, although it is not indicated for it.

But besides medication, experts say that lifestyle should also be considered. Discussions about libido almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem recommending 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 increasing libido include:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• engaging in extended foreplay
• using sexual wellness devices or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexuality and this life stage in later life,” said an OB-GYN. “This involves 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 peak of orgasm.”