U.S. Food and Drug Administration Clears Addyi, a Desire-Boosting Treatment for Postmenopausal

U.S. regulators widened the indication of a daily pill to address hypoactive sexual desire disorder (HSDD) in females to now encompass postmenopausal women up to the age of sixty-five.

Prior to the announcement, the pill, Addyi (flibanserin), was exclusively cleared to treat low sexual desire in premenopausal females.

The drug was originally authorized by the FDA in 2015, following a lengthy and contentious evaluation period.

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

Now, flibanserin is the sole oral drug cleared by the FDA 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 maker of flibanserin applauded the FDA’s decision to expand the drug’s approval, calling it a “landmark event” in understanding and prioritizing female sexual health.

Additional women’s health experts expressed support for the regulatory move.

“I had few tools for me to recommend because everything was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Getting the FDA approval for this patient population could be significant to help postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told reporters that the approval was “logical” given the clinical evidence.

While in favor, the expert was cautious in her assessment: “The studies showed a meaningful difference of the drug over the placebo, but the degree of the benefit is not dramatic. Does it justify taking a drug daily and not getting bang for your buck?”

What is Addyi, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “the women's version of Viagra,” has little in common with the medication from which it draws its nickname.

This medication was initially researched as an medication for depression but was found to be lacking during early studies.

Nevertheless, scientists observed positive changes in measures of libido and arousal and shifted focus to the drug’s possible use as a treatment for diminished sexual desire.

Following initial denials, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a significant advocacy campaign.

The medication carries a serious safety warning for serious adverse reactions, including a drop in blood pressure and fainting (syncope), when taken alongside alcoholic drinks.

The label recommends waiting at least two hours after consuming alcohol before taking Addyi to minimize the chance of fainting. If a person has several drinks on a single occasion, the label advises skipping the dose entirely.

Assertions about the effects of mixing the drug with drinking eventually prompted the pharmaceutical company to fund additional studies investigating the interaction. The studies, which were small in scale, showed no increased danger of fainting. But medical professionals had reservations.

“This research aren't very convincing to me. They are a beginning, but they’re not very large-scale and certainly aren’t very long,” a public health expert stated.

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

“Patients have experienced side effects like the fainting spells 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 echoed uncertainty about why the expanded indication was capped at age 65.

“I don’t know if that has to do with the complexity of the medication. If you take a list of the instructions and restrictions, they are extensive. Now that this has been cleared, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Addressing Low Libido in Postmenopausal Women

Despite these risks, Addyi could still broaden therapeutic choices for low desire to a new population of women who may find help.

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

But it is not a quick fix. In fact, the experts consulted universally acknowledged that the female libido is complex and multifaceted.

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

Postmenopausal females experience a broad range of symptoms that can affect libido. Symptoms of menopause encompass:

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

As noted by one expert, treating these symptoms is often a first step toward improved intimacy.

“When a patient presents with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

The expert recommended both vaginal estrogen and hormone replacement therapy (HRT) as treatments 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 women to feel less concerned about it and to consider it as a viable choice.

Androgen therapy is also occasionally prescribed off-label 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. Discussions about libido almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable recommending 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 increasing sexual desire include:

• improving sleep hygiene
• engaging in physical activity
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• practicing extended intimate stimulation
• incorporating vibrators or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexuality and this life stage in older age,” said an expert. “This involves knowing how your body works, your physiology, 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 orgasm.”