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U.S. regulators widened the indication of a oral treatment to manage hypoactive sexual desire disorder (HSDD) in females to include women after menopause up to 65 years old.

Before the recent news, the pill, flibanserin (Addyi), was solely authorized to address low sexual desire in women of reproductive age.

The drug was first approved by the FDA in 2015, following a lengthy and contentious evaluation period.

The agency had denied approval for the drug on two separate occasions, in 2010 and 2013. In each instance, the FDA cited issues about safety, efficacy, and an unfavorable risk–benefit profile.

Now, Addyi is the exclusive pill authorized for HSDD, though the FDA approved Vyleesi (bremelanotide), an on-demand injection, in two thousand nineteen.

The chief executive of the pharmaceutical company of flibanserin commended the FDA’s move to broaden the drug’s indication, calling it a “significant step” in understanding and prioritizing female sexual health.

Other OB-GYNs were supportive for the decision.

“Previously, options were limited for me to prescribe because everything was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this group of women could be crucial to address postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

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

While in favor, the expert was measured in her assessment: “The studies showed statistical significance of the drug over the placebo, but the degree of the enhancement is not overwhelming. Is it worthwhile taking a drug daily and not getting bang for your buck?”

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

Flibanserin, which is sometimes referred to as “the women's version of Viagra,” has few similarities with the medication from which it gets its informal name.

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

However, researchers noted positive changes in aspects of sexual function and shifted focus to the drug’s potential as a treatment for diminished sexual desire.

Following initial denials, flibanserin was approved in 2015 to treat HSDD, following further studies and a considerable lobbying effort.

Addyi carries a serious safety warning for severe side effects, including a drop in blood pressure and loss of consciousness, when taken alongside alcohol.

The label advises waiting at least two hours after consuming alcohol before taking Addyi to reduce the risk of syncope. If a person has several drinks on a single occasion, the label advises skipping the dose entirely.

Assertions about the effects of combining Addyi and alcohol eventually led the maker to fund additional studies investigating the interaction. The studies, which were limited in size, showed no increased danger of fainting. But medical professionals had reservations.

“These studies don’t seem very convincing to me. They are a beginning, but they’re not very big and certainly are short-term,” a public health expert stated.

An OB-GYN speculated that this may have been part of the cause why Addyi was not originally approved for postmenopausal women.

“There have been side effects like the syncopal episodes and lightheadedness especially in persons who have had an drink within two hours of treatment. When you get more advanced in age, you become more sensitive to things like that,” she said.

Another doctor expressed confusion about why the broader approval was limited at age 65.

“It's unclear if that has to do with the complexity of the drug. Reviewing a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Treating Low Libido in Postmenopausal Women

Despite these risks, flibanserin could still broaden therapeutic choices for low desire to a new population of females who may find help.

“I do think 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 interviewed all agreed that the female libido is influenced by many factors.

So treating HSDD means considering everything from partnership issues to hormonal changes.

Women after menopause experience a wide variety of changes that can affect sexual desire. Menopausal symptoms encompass:

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

According to 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? Is intercourse painful?” she said.

The expert recommended both vaginal estrogen and systemic hormone therapy as treatments to alleviate the effects of menopause, particularly dryness.

She expressed hope that the FDA’s recent removal of its “black box” warning on hormone therapy will lead more females to feel less concerned about it and to view it as a treatment option.

Testosterone is also sometimes used without formal approval to treat low libido in females, although it is not indicated for it.

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

“I am comfortable prescribing Addyi after having a conversation with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Additional suggestions for increasing sexual desire include:

• improving sleep hygiene
• engaging in physical activity
• staying active
• using over-the-counter personal lubricants
• practicing extended intimate stimulation
• using sexual wellness devices or dilators

“You have to take an comprehensive, holistic strategy to sexual health and this life stage in later life,” said an OB-GYN. “This involves understanding 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 sexual pleasure.”