🔗 Share this article

U.S. regulators widened the indication of a daily pill to treat low libido in females to cover women after menopause up to 65 years old.

Prior to the recent news, the medication, flibanserin (Addyi), was only approved to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

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

Regulators had earlier turned down the drug on two separate occasions, in 2010 and again in 2013. In both cases, the FDA raised concerns about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Now, flibanserin is the exclusive pill authorized for HSDD, though the FDA approved bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of flibanserin praised the FDA’s decision to broaden the drug’s indication, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Additional OB-GYNs were supportive for the regulatory move.

“There was nothing for me to prescribe because available treatments was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this group of women could be very important 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 guarded in her assessment: “The studies showed statistical significance of the drug over the inactive pill, but the magnitude of the improvement is not overwhelming. Does it justify taking a drug every single day and not experiencing a dramatic change?”

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

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

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 redirected efforts to the drug’s potential as a therapy for diminished sexual desire.

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

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

The label recommends waiting at least two hours after consuming alcohol before taking the drug to minimize the chance of fainting. If a person has three or more alcoholic drinks on a given day, the instructions advises skipping the dose entirely.

Assertions about the interactions of combining the drug with drinking eventually led the maker to fund further research examining the interaction. The studies, which were limited in size, demonstrated no additional risk of syncope. But medical professionals had reservations.

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

An OB-GYN suggested that this may have been part of the cause why Addyi was not originally approved for older females.

“Patients have experienced adverse reactions like the syncopal episodes and lightheadedness especially in persons who have had an alcoholic beverage within two hours of taking the pill. When you get more advanced in age, you become more susceptible to things like that,” she said.

Another doctor expressed confusion about why the expanded indication was limited at age 65.

“I don’t know if that has to do with the intricacies of the medication. If you take a list of the dos and don’ts, 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 Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, Addyi could still expand treatment options 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 quick fix. In fact, the specialists interviewed all agreed that the female libido is influenced by many factors.

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

Postmenopausal females experience a wide variety of symptoms that can affect sexual desire. Menopausal symptoms include:

• hot flashes
• lack of natural lubrication
• pain during intercourse
• insomnia
• bladder leakage

As noted by one expert, treating these issues is often a initial approach toward improved intimacy.

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

The expert suggested both vaginal estrogen and hormone replacement therapy (HRT) as options to treat the symptoms of menopause, particularly 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 viable choice.

Androgen therapy is also sometimes used without formal approval to address low libido in females, although it is not officially approved for it.

But besides medication, doctors say that lifestyle should also be considered. Discussions about libido almost always start with relationships and intimacy.

“I am comfortable recommending 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.

Additional suggestions for boosting sexual desire are:

• getting more sleep
• exercising
• maintaining an active lifestyle
• applying over-the-counter lubricants
• practicing extended foreplay
• using sexual wellness devices or dilators

“You have to take an comprehensive, holistic strategy to sexuality and menopause in older age,” said an expert. “That means knowing 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 climax of orgasm.”