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The federal agency broadened the authorized use of a oral treatment to manage low libido in women to now encompass postmenopausal women up to 65 years old.

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

Flibanserin was initially cleared by the FDA in two thousand fifteen, following a long and debated evaluation period.

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In both cases, the FDA expressed reservations about safety, efficacy, and an unfavorable risk–benefit profile.

Today, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in 2019.

The founder and CEO of the pharmaceutical company of flibanserin praised the FDA’s decision to expand the drug’s approval, calling it a “landmark event” in advancing and focusing on women's sexual wellness.

Other specialists in female health were supportive for the regulatory move.

“There was nothing for me to prescribe because available treatments was for women who were premenopausal and not menopausal,” said an OB-GYN. “Securing the FDA approval for this group of women could be significant 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 decision was “logical” given the clinical evidence.

Although supportive, the expert was guarded in her evaluation: “The studies showed statistical significance of the drug over the inactive pill, but the magnitude of the benefit is not dramatic. Does it justify taking a drug every single day and not seeing a major effect?”

Understanding Addyi, the ‘Female Viagra’?

Addyi, which is often called “female Viagra,” has significant differences with the medication from which it draws its nickname.

The drug was originally developed as an medication for depression but was considered unsuccessful during early studies.

However, researchers noted improvements in measures of sexual function and redirected efforts to the drug’s potential 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 significant advocacy campaign.

Addyi carries a boxed (“black box”) warning for potentially dangerous side effects, including a drop in blood pressure and loss of consciousness, when combined with alcoholic drinks.

Official guidance advises waiting at least two hours after drinking before taking Addyi to reduce the chance of fainting. If a person has several drinks on a single occasion, the instructions recommends skipping the dose entirely.

Claims about the interactions of combining the drug with drinking eventually led the pharmaceutical company to fund additional studies investigating the interaction. The research, which were small in scale, showed no additional risk of syncope. 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 aren’t very long,” a public health expert stated.

An OB-GYN speculated that this may have been part of the cause why the drug was not initially cleared for postmenopausal women.

“There have been side effects like the fainting spells 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 susceptible to effects like that,” she said.

Another doctor echoed confusion about why the expanded indication was capped at age 65.

“I don’t know if that has to do with the intricacies of the medication. Reviewing a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Addressing Diminished Sexual Desire After Menopause

Notwithstanding the warnings, flibanserin could still broaden therapeutic choices for HSDD to a new population of women who may find help.

“I do think it will serve this demographic better as long as they have no other health issues,” said an specialist.

But it is not a quick fix. In fact, the experts interviewed universally acknowledged that the female libido is complex and multifaceted.

So addressing low desire means considering everything from partnership issues to shifts in hormone levels.

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

• hot flashes
• vaginal dryness
• discomfort with sex
• insomnia
• bladder leakage

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

“If somebody came to me with libido issues, my first question is: How’s your vagina feeling? Is intercourse painful?” she said.

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

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

Androgen therapy is also sometimes prescribed off-label to address low libido in females, although it is not indicated for it.

But besides medication, doctors say that lifestyle should also be factored in. Discussions about libido 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.

Other recommendations for boosting libido include:

• improving sleep hygiene
• engaging in physical activity
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• engaging in extended intimate stimulation
• using vibrators or vaginal dilators

“You have to take an entire whole body approach to sexuality and menopause in later life,” said an OB-GYN. “This involves 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 orgasm.”