FDA Approves Addyi, a Desire-Boosting Treatment for Females Beyond Menopause

The Food and Drug Administration (FDA) expanded its approval of a oral treatment to treat low libido in females to now encompass women after menopause up to age 65.

Prior to this week's decision, the pill, flibanserin (Addyi), was only approved to address low sexual desire in premenopausal females.

Flibanserin was initially cleared by the FDA in two thousand fifteen, following a lengthy and contentious regulatory scrutiny.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA cited issues about safety, effectiveness, and an concerning balance of risks and benefits.

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

The chief executive of the maker of flibanserin applauded the FDA’s move to expand 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.

“There was nothing for me to prescribe because everything was for women who were menstrual and not menopausal,” said an OB-GYN. “Getting the FDA approval for this patient population could be significant to address women after menopause 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 approval was “understandable” given the available data.

While in favor, the expert was measured in her assessment: “The studies showed a meaningful difference of the drug over the placebo, but the extent of the benefit is not substantial. Does it justify taking a drug daily and not experiencing a dramatic change?”

Understanding Flibanserin, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “female Viagra,” has few similarities with the drug from which it gets its informal name.

This medication was first created as an medication for depression but was deemed ineffective during initial trials.

Nevertheless, scientists noted positive changes in measures of libido and arousal 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 advocacy campaign.

Addyi carries a serious safety warning for potentially dangerous side effects, including a drop in blood pressure and loss of consciousness, when combined with alcohol.

Official guidance advises waiting at least two hours after consuming alcohol before taking Addyi to reduce the risk of syncope. If a person has several drinks on a single occasion, the instructions recommends not taking the pill entirely.

Assertions about the effects of mixing the drug with drinking eventually prompted the pharmaceutical company to fund additional studies investigating the combination. The research, which were limited in size, demonstrated 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 large-scale 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 initially cleared for postmenopausal women.

“Patients have experienced adverse reactions like the syncopal episodes and dizziness especially in persons 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 echoed uncertainty about why the broader approval was capped at 65 years of age.

“It's unclear 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 cleared, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Addressing Low Libido After Menopause

Notwithstanding the warnings, flibanserin could still expand treatment options for low desire to a different group of women who may benefit.

“I do think it will serve this demographic 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 all agreed that the female libido is influenced by many factors.

So treating low desire means considering everything from relationship dynamics to shifts in hormone levels.

Postmenopausal females experience a wide variety of symptoms that can impact sexual desire. Symptoms of menopause encompass:

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

According to one expert, treating these issues is often a first step toward sexual wellness.

“If somebody came to me with concerns about desire, 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 options to alleviate the effects of menopause, particularly vaginal dryness.

She hopes that the regulatory decision to lift of its “black box” warning on HRT will lead more women to feel less concerned about it and to view it as a treatment option.

Testosterone is also occasionally used without formal approval to treat low libido in women, although it is not officially approved for it.

But in addition to drugs, experts say that personal habits should also be considered. Discussions about libido almost always begin by focusing on relationships and intimacy.

“I would have no problem recommending 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 boosting sexual desire include:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• engaging in extended intimate stimulation
• incorporating sexual wellness devices or dilators

“It requires an comprehensive, holistic strategy to sexual health and menopause in older age,” 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 aroused, and ultimately to have a peak of sexual pleasure.”