FDA Clears Addyi, a Libido-Enhancing Drug for Postmenopausal

The federal agency broadened the authorized use of a daily pill to treat hypoactive sexual desire disorder (HSDD) in females to now encompass postmenopausal women up to age 65.

Before the recent news, the pill, flibanserin (Addyi), was solely authorized to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

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

The agency had denied approval for the drug on two separate occasions, in 2010 and again in 2013. In each instance, the FDA expressed reservations about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Now, Addyi is the exclusive pill authorized for HSDD, though the FDA approved bremelanotide (Vyleesi), an on-demand injection, in two thousand nineteen.

The founder and CEO of the maker of flibanserin commended the FDA’s action to expand the drug’s indication, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Additional OB-GYNs voiced approval for the decision.

“There was nothing for me to prescribe because available treatments was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Getting the FDA clearance for this patient population could be very important to help postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

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

Although supportive, the expert was cautious in her evaluation: “The studies showed a meaningful difference of the drug over the placebo, but the degree of the benefit is not substantial. Is it worthwhile taking a drug daily and not getting bang for your buck?”

Understanding Addyi, the ‘Female Viagra’?

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

This medication was initially researched as an antidepressant but was considered unsuccessful during initial trials.

Nevertheless, researchers noted improvements in aspects of sexual function and shifted focus to the drug’s possible use as a treatment for diminished sexual desire.

After two rejections, flibanserin was cleared in 2015 to treat HSDD, following further studies and a major lobbying effort.

Addyi carries a boxed (“black box”) warning for potentially dangerous adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcohol.

The label recommends waiting at least two hours after consuming alcohol before using the drug to reduce the chance of fainting. If a person consumes several drinks on a given day, the instructions recommends not taking the pill entirely.

Assertions about the effects of mixing Addyi and alcohol eventually led the pharmaceutical company to fund additional studies investigating the combination. The studies, which were small in scale, demonstrated no additional risk of syncope. But medical professionals had concerns.

“This research don’t seem 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 cause why the drug was not originally approved for older females.

“There have been side effects like the syncopal episodes and lightheadedness especially in persons who have had an drink 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 echoed confusion about why the broader approval was capped 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 approved, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire After Menopause

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

“I believe it will benefit this population better as long as they have no other medical problems,” said an OB-GYN.

But it is not a quick fix. In fact, the experts interviewed all agreed that the women's sexual desire is complex and multifaceted.

So addressing HSDD means considering everything from relationship dynamics to shifts in hormone levels.

Postmenopausal females experience a wide variety of changes that can affect libido. Symptoms of menopause include:

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

According to one expert, managing these symptoms is often a initial approach toward sexual wellness.

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

The expert suggested both vaginal estrogen and hormone replacement therapy (HRT) as treatments to treat the symptoms 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 concerned about it and to view it as a treatment option.

Androgen therapy is also occasionally used without formal approval to treat reduced desire in women, although it is not indicated for it.

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

“I am comfortable recommending 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.

Additional recommendations for boosting sexual desire include:

• improving sleep hygiene
• exercising
• staying active
• applying over-the-counter lubricants
• engaging in extended foreplay
• incorporating vibrators or vaginal dilators

“It requires an comprehensive, holistic strategy to sexuality and this life stage in older age,” said an expert. “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.”