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U.S. regulators expanded its approval of a daily pill to treat hypoactive sexual desire disorder (HSDD) in women to cover postmenopausal women up to age 65.

Before the recent news, the drug, Addyi (flibanserin), was exclusively cleared to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

Flibanserin was initially cleared by the FDA in 2015, following a lengthy and contentious review process.

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

Currently, Addyi is the exclusive pill authorized for HSDD, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in 2019.

The founder and CEO of the pharmaceutical company of flibanserin applauded the FDA’s move to expand the drug’s approval, calling it a “milestone” in understanding and prioritizing women's sexual wellness.

Other specialists in female health were supportive for the decision.

“There was nothing for me to recommend because available treatments was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Securing the FDA approval for this group of women could be significant to help postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told news outlets that the decision was “understandable” given the clinical evidence.

While in favor, the expert was guarded in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the extent of the improvement is not overwhelming. Is it worthwhile taking a drug every single day and not seeing a major effect?”

Understanding Flibanserin, the ‘Female Viagra’?

Flibanserin, which is often called “female Viagra,” has significant differences with the medication from which it gets its informal name.

The drug was first created as an medication for depression but was deemed ineffective during early studies.

Nevertheless, scientists observed positive changes in measures of sexual function and shifted focus to the drug’s possible use as a therapy for diminished sexual desire.

Following initial denials, 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 severe side effects, including a drop in blood pressure and fainting (syncope), when combined with alcoholic drinks.

The label advises waiting at least two hours after consuming alcohol before taking Addyi to minimize the risk of fainting. If a person consumes several drinks on a given day, the label recommends not taking the pill entirely.

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

“These studies aren't very convincing to me. They are a beginning, but they’re not very large-scale and certainly are short-term,” a health research president stated.

An OB-GYN speculated that this may have been part of the cause 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 older, you become more sensitive to things like that,” she said.

Another doctor expressed uncertainty about why the expanded indication was limited 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 instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Treating Low Libido After Menopause

Notwithstanding the warnings, flibanserin could still broaden treatment options for HSDD to a different group of females who may find help.

“I believe it will benefit this population better as long as they have no other medical problems,” said an OB-GYN.

But it is not a magic bullet. In fact, the specialists interviewed universally acknowledged that the female libido is influenced by many factors.

So treating HSDD means engaging with everything from partnership issues to shifts in hormone levels.

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

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• insomnia
• bladder leakage

As noted by one expert, treating these issues is often a first step toward sexual wellness.

“If somebody came to me with libido issues, my initial inquiry is: How’s your vagina feeling? Are you comfortable?” she said.

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

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

Testosterone is also occasionally used without formal approval to treat reduced desire in females, although it is not officially approved for it.

But in addition to drugs, experts say that personal habits should also be factored in. Conversations about sexual desire almost always start with partnership dynamics and closeness.

“I would have no problem prescribing Addyi after having a conversation with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Other recommendations for increasing sexual desire include:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• applying over-the-counter lubricants
• engaging in extended intimate stimulation
• using sexual wellness devices or dilators

“It requires an comprehensive, holistic strategy to sexual health and this life stage in older age,” said an OB-GYN. “That means understanding how your body works, your anatomy, and your sexual needs — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of sexual pleasure.”