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U.S. regulators expanded its approval of a daily pill to treat hypoactive sexual desire disorder (HSDD) in women to now encompass women after menopause up to the age of sixty-five.

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

The drug was first approved by the FDA in two thousand fifteen, following a protracted and controversial review process.

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

Today, Addyi is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in 2019.

The chief executive of the pharmaceutical company of Addyi commended the FDA’s move to expand the drug’s approval, calling it a “landmark event” in advancing and focusing on women's sexual wellness.

Other OB-GYNs were supportive for the regulatory move.

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

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

Although supportive, the expert was cautious in her assessment: “Clinical trials showed a meaningful difference of the drug over the placebo, but the extent of the benefit is not dramatic. Is it worthwhile taking a drug every single day and not seeing a major effect?”

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

Flibanserin, which is sometimes referred to as “female Viagra,” has little in common with the drug from which it gets its informal name.

This medication was initially researched as an medication for depression but was considered unsuccessful during early studies.

However, scientists observed improvements in aspects of libido and arousal and redirected efforts to the drug’s potential as a therapy for diminished sexual desire.

Following initial denials, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a significant lobbying effort.

The medication carries a serious safety warning for potentially dangerous side effects, including a drop in blood pressure and fainting (syncope), when taken alongside alcohol.

The label advises allowing a two-hour gap after consuming alcohol before taking Addyi to minimize the chance of syncope. If a person consumes several drinks on a single occasion, the instructions advises skipping the dose entirely.

Assertions about the effects of mixing Addyi and alcohol eventually prompted the maker to fund further research examining the interaction. The research, which were small in scale, showed no increased danger of syncope. But experts had reservations.

“This research don’t seem very convincing to me. They are a good start, but they’re not very large-scale and certainly aren’t very long,” 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.

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

Another doctor echoed uncertainty about why the broader approval was capped at 65 years of age.

“I don’t know if that has to do with the complexity of the drug. Reviewing a list of the dos and don’ts, 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.

Treating Diminished Sexual Desire After Menopause

Notwithstanding the warnings, flibanserin could still expand treatment options 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 medical problems,” said an OB-GYN.

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

So addressing low desire means considering everything from partnership issues to hormonal changes.

Postmenopausal females experience a wide variety of symptoms that can affect libido. Menopausal symptoms encompass:

• hot flashes
• vaginal dryness
• pain during intercourse
• insomnia
• urinary incontinence

As noted by one expert, managing these issues is often a first step toward improved intimacy.

“When a patient presents with concerns about desire, my initial inquiry is: How’s your vagina feeling? Are you comfortable?” she said.

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

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

Androgen therapy is also occasionally prescribed off-label to address reduced desire in women, although it is not indicated for it.

But in addition to drugs, experts say that lifestyle should also be factored in. Conversations about libido almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem recommending 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 are:

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

“You have to take an entire whole body approach to sexuality and this life stage in later life,” 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 peak of orgasm.”