FDA Grants Approval to Flibanserin, a Libido-Enhancing Treatment for Women After Menopause

The Food and Drug Administration (FDA) widened the indication of a daily pill to address hypoactive sexual desire disorder (HSDD) in women to cover women after menopause up to the age of sixty-five.

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

This medication was first approved by the FDA in two thousand fifteen, following a protracted and controversial regulatory scrutiny.

Regulators had earlier turned down the drug on two separate occasions, in 2010 and again in 2013. In each instance, the FDA raised concerns about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Currently, Addyi is the sole oral drug cleared by the FDA for HSDD, though the FDA approved bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

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

Additional OB-GYNs expressed support for the regulatory move.

“Previously, options were limited for me to prescribe because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this patient population could be crucial to address postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told reporters that the decision was “logical” given the existing research.

While in favor, the expert was measured in her assessment: “The studies showed statistical significance of the drug over the placebo, but the magnitude of the improvement is not substantial. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?”

Understanding Flibanserin, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “female Viagra,” has significant differences with the medication from which it draws its nickname.

This medication was first created as an antidepressant but was considered unsuccessful during early studies.

Nevertheless, researchers noted improvements in aspects of sexual function and redirected efforts to the drug’s potential as a treatment for low libido.

After two rejections, Addyi was cleared in 2015 to treat HSDD, following additional research and a considerable advocacy campaign.

The medication carries a serious safety warning for severe side effects, including a drop in blood pressure and loss of consciousness, when combined with alcohol.

The label recommends allowing a two-hour gap after consuming alcohol before using Addyi to minimize the chance of fainting. If a person has three or more alcoholic drinks on a single occasion, the label advises not taking the pill entirely.

Claims about the interactions of mixing Addyi and alcohol eventually prompted the maker to fund additional studies examining the interaction. The research, which were limited in size, demonstrated no additional risk of syncope. But medical professionals had reservations.

“These studies don’t seem very persuasive 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 Addyi was not originally approved for postmenopausal women.

“Patients have experienced adverse reactions like the syncopal episodes and dizziness especially in persons who have had an drink within two hours of taking the pill. When you get older, you become more susceptible to effects 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 medication. If you take a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been approved, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Treating Low Libido After Menopause

Despite these risks, Addyi could still expand therapeutic choices for low desire to a different group of females who may find help.

“I believe it will serve this population better as long as they have no other medical problems,” said an specialist.

But it is not a magic bullet. In fact, the specialists consulted universally acknowledged that the women's sexual desire is influenced by many factors.

So addressing HSDD means considering everything from relationship dynamics to hormonal changes.

Women after menopause navigate a wide variety of symptoms that can affect libido. Menopausal symptoms include:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• insomnia
• bladder leakage

According to one expert, managing these issues is often a initial approach toward improved intimacy.

“When a patient presents 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 systemic hormone therapy as treatments to treat the effects of menopause, particularly vaginal dryness.

She hopes that the FDA’s recent removal of its “serious” warning on HRT will lead more females to feel less concerned about it and to consider it as a treatment option.

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

But besides medication, doctors say that lifestyle should also be factored in. Conversations about sexual desire almost always start with relationships and intimacy.

“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.

Additional suggestions for boosting sexual desire include:

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

“It requires an comprehensive, holistic strategy to sexual health and this life stage in later life,” said an OB-GYN. “That means knowing how your body works, your anatomy, 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.”