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U.S. regulators broadened the authorized use of a once-a-day medication to treat hypoactive sexual desire disorder (HSDD) in females to cover women after menopause up to age 65.

Prior to this week's decision, the pill, Addyi (flibanserin), was exclusively cleared to treat low sexual desire in women of reproductive age.

This medication was first approved by the FDA in two thousand fifteen, following a long and debated regulatory scrutiny.

The agency had denied approval for the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA cited issues about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Now, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of Addyi praised the FDA’s move to broaden the drug’s approval, calling it a “landmark event” in advancing and focusing on female sexual health.

Additional specialists in female health expressed support for the regulatory move.

“Previously, options were limited for me to prescribe because available treatments was for women who were menstrual and not menopausal,” said an OB-GYN. “Getting the FDA approval for this patient population could be crucial to address women after menopause who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told reporters that the approval was “logical” given the existing research.

Although supportive, the expert was cautious in her evaluation: “The studies showed a meaningful difference of the drug over the placebo, but the degree of the improvement is not substantial. Does it justify taking a drug every single day and not seeing a major effect?”

Understanding Flibanserin, the ‘Female Viagra’?

Addyi, which is often called “female Viagra,” has few similarities with the drug from which it draws its nickname.

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

However, researchers noted improvements in aspects of libido and arousal and redirected efforts to the drug’s possible use as a therapy for low libido.

Following initial denials, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a considerable lobbying effort.

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

Official guidance advises allowing a two-hour gap after drinking before using Addyi to minimize the chance of syncope. If a person consumes three or more alcoholic drinks on a given day, the label recommends skipping the dose entirely.

Assertions about the interactions of mixing the drug with drinking eventually led the pharmaceutical company to fund additional studies examining the interaction. The research, which were small in scale, demonstrated no increased danger of fainting. But experts had concerns.

“These studies aren't 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 reason why the drug was not initially cleared for postmenopausal women.

“Patients have experienced side effects like the syncopal episodes and dizziness especially in individuals who have had an alcoholic beverage within two hours of taking the pill. When you get more advanced in age, you become more susceptible to effects like that,” she said.

Another doctor echoed confusion about why the expanded indication 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 cleared, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, Addyi could still broaden therapeutic choices for low desire 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 magic bullet. In fact, the specialists consulted universally acknowledged that the female libido is complex and multifaceted.

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

Women after menopause experience a broad range of changes that can affect sexual desire. Symptoms of menopause encompass:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• bladder leakage

According to one expert, treating these issues is often a initial approach toward improved intimacy.

“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 suggested both topical estrogen therapy and systemic hormone therapy as options to treat the symptoms of menopause, particularly dryness.

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

Androgen therapy is also sometimes prescribed off-label to treat reduced desire in females, although it is not officially approved for it.

But besides medication, doctors say that lifestyle should also be factored in. Discussions about libido almost always start with relationships and intimacy.

“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 recommendations for boosting libido include:

• getting more sleep
• exercising
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• practicing extended foreplay
• incorporating vibrators or dilators

“It requires an entire whole body approach to sexual health and menopause in older age,” said an expert. “This involves knowing how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of orgasm.”