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The federal agency expanded its approval of a oral treatment to treat hypoactive sexual desire disorder (HSDD) in females to cover women after menopause up to 65 years old.

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

Flibanserin was originally authorized by the FDA in two thousand fifteen, following a protracted and controversial evaluation period.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In each instance, 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 cleared Vyleesi (bremelanotide), an injectable used when desired, in two thousand nineteen.

The chief executive of the maker of Addyi praised the FDA’s decision to broaden the drug’s approval, calling it a “milestone” in understanding and prioritizing women's sexual wellness.

Additional OB-GYNs were supportive for the decision.

“Previously, options were limited for me to recommend because everything was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Getting the FDA approval for this patient population could be crucial to help postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

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

Although supportive, the expert was measured in her evaluation: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the magnitude of the benefit is not overwhelming. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?”

Understanding Addyi, the ‘Female Viagra’?

Flibanserin, which is often called “female Viagra,” has little in common with the medication from which it draws its nickname.

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

However, scientists noted positive changes in aspects of sexual function and shifted focus to the drug’s possible use as a treatment for low libido.

After two rejections, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a major advocacy campaign.

The medication carries a boxed (“black box”) warning for serious side effects, including a drop in blood pressure and loss of consciousness, when taken alongside alcohol.

The label advises allowing a two-hour gap after drinking before using the drug to minimize the chance of syncope. If a person consumes three or more alcoholic drinks on a single occasion, the instructions advises skipping the dose entirely.

Claims about the effects of combining the drug with drinking eventually prompted the maker to fund further research investigating the interaction. The research, which were limited in size, demonstrated no increased danger of fainting. But medical professionals had reservations.

“These studies 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 public health expert stated.

An OB-GYN suggested that this may have been part of the reason why the drug was not originally approved for postmenopausal women.

“Patients have experienced adverse reactions like the fainting spells and dizziness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get older, you become more sensitive to things like that,” she said.

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

“It's unclear if that has to do with the complexity of the drug. If you take a list of the instructions and restrictions, they are extensive. 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 Low Libido After Menopause

Notwithstanding the warnings, Addyi could still expand treatment options for low desire to a different group of females who may find help.

“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 quick fix. In fact, the specialists consulted all agreed that the women's sexual desire is influenced by many factors.

So treating HSDD means engaging with everything from relationship dynamics to hormonal changes.

Postmenopausal females navigate 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, treating these issues is often a initial approach toward sexual wellness.

“If somebody came to me with libido issues, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

She expressed hope that the regulatory decision to lift of its “black box” warning on HRT will lead more females to feel less apprehensive about it and to consider it as a viable choice.

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

But besides medication, doctors say that personal habits should also be factored in. Conversations about libido almost always begin by focusing on relationships and intimacy.

“I would have no problem prescribing 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.

Other suggestions for boosting sexual desire are:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• using over-the-counter lubricants
• practicing extended foreplay
• using vibrators or vaginal dilators

“It requires an entire whole body approach to sexuality and menopause in later life,” said an expert. “That means 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 sexual pleasure.”