FDA Approves Flibanserin, a Desire-Boosting Medication for Women After Menopause

The federal agency broadened the authorized use of a daily pill to address hypoactive sexual desire disorder (HSDD) in females to include women after menopause up to 65 years old.

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

The drug was initially cleared by the FDA in two thousand fifteen, following a protracted and controversial evaluation period.

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA expressed reservations about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Now, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an as-needed injectable treatment, in two thousand nineteen.

The chief executive of the pharmaceutical company of Addyi praised the FDA’s decision to broaden the drug’s approval, calling it a “milestone” in understanding and prioritizing women's sexual wellness.

Additional specialists in female health were supportive for the decision.

“I had few tools for me to prescribe because everything was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this group of women could be very important to address women after menopause who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told news outlets that the decision was “quite reasonable” given the available data.

Although supportive, the expert was measured in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the degree of the benefit is not substantial. Does it justify taking a drug daily and not seeing a major effect?”

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

Addyi, which is sometimes referred to as “the women's version of Viagra,” has significant differences with the drug from which it draws its nickname.

The drug was originally developed as an medication for depression but was found to be lacking during initial trials.

Nevertheless, researchers noted improvements in aspects of libido and arousal and redirected efforts to the drug’s potential as a therapy for diminished sexual desire.

Following initial denials, Addyi was cleared in 2015 to treat HSDD, following additional research and a major lobbying effort.

Addyi carries a serious safety warning for potentially dangerous adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcohol.

The label advises waiting at least two hours after drinking before using the drug to reduce the risk of fainting. If a person has three or more alcoholic drinks on a given day, the instructions recommends not taking the pill entirely.

Claims about the effects of mixing Addyi and alcohol eventually led the pharmaceutical company to fund additional studies investigating the interaction. The research, which were limited in size, demonstrated no increased danger of syncope. But medical professionals had concerns.

“This research aren't very persuasive to me. They are a good start, but they’re not very big and certainly aren’t very long,” a health research president stated.

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

“There have been adverse reactions like the fainting spells and lightheadedness especially in individuals who have had an alcoholic beverage within two hours of taking the pill. When you get older, you become more susceptible to effects like that,” she said.

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

“I don’t know if that has to do with the complexity of the drug. If you take a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been cleared, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Despite these risks, flibanserin could still expand treatment options for low desire to a new population of females who may benefit.

“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 quick fix. In fact, the specialists consulted all agreed that the female libido is influenced by many factors.

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

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

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

According to 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? Are you comfortable?” she said.

The expert suggested both topical estrogen therapy and systemic hormone therapy as options to alleviate the effects of menopause, particularly dryness.

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

Androgen therapy is also occasionally used without formal approval to treat low libido in females, although it is not indicated for it.

But besides medication, experts say that lifestyle should also be factored in. Discussions about sexual desire almost always begin by focusing on relationships and intimacy.

“I would have no problem prescribing flibanserin 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 recommendations for increasing libido are:

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

“You have to take 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 orgasm.”