🔗 Share this article

U.S. regulators widened the indication of a daily pill to manage hypoactive sexual desire disorder (HSDD) in women to include women after menopause up to 65 years old.

Before the announcement, the drug, Addyi (flibanserin), was only approved to address low sexual desire in women of reproductive age.

Flibanserin was initially cleared by the FDA in two thousand fifteen, following a protracted and controversial review process.

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In each instance, the FDA cited issues about its safety profile, efficacy, and an concerning balance of risks and benefits.

Currently, Addyi is the only FDA-approved oral medication for HSDD, though the FDA approved Vyleesi (bremelanotide), an on-demand injection, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of flibanserin praised the FDA’s decision to broaden the drug’s approval, 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 recommend because available treatments was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Securing the FDA clearance for this group of women could be crucial to help postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told news outlets that the decision was “logical” given the existing research.

While in favor, the expert was cautious in her evaluation: “Clinical trials showed statistical significance of the drug over the placebo, but the degree of the benefit is not substantial. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?”

Understanding Addyi, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “the women's version of Viagra,” has few similarities 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 initial trials.

Nevertheless, scientists observed improvements in measures of libido and arousal and shifted focus to the drug’s possible use as a treatment for low libido.

After two rejections, flibanserin was cleared in 2015 to treat HSDD, following additional research and a major advocacy campaign.

Addyi carries a serious safety warning for severe side effects, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcoholic drinks.

The label advises allowing a two-hour gap after consuming alcohol before taking the drug to reduce the risk of syncope. If a person consumes three or more alcoholic drinks on a single occasion, the label advises not taking the pill entirely.

Claims about the effects of mixing the drug with drinking eventually led the pharmaceutical company to fund additional studies investigating the combination. The studies, which were limited in size, demonstrated no increased danger of fainting. But medical professionals had reservations.

“This research don’t seem very persuasive to me. They are a good start, 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 the drug was not initially cleared for postmenopausal women.

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

Another doctor echoed uncertainty 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. Reviewing a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Treating Low Libido After Menopause

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

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

But it is not a magic bullet. In fact, the experts interviewed all agreed that the female libido is influenced by many factors.

So addressing low desire means engaging with everything from relationship dynamics to hormonal changes.

Women after menopause experience a wide variety of changes that can impact sexual desire. Symptoms of menopause encompass:

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• insomnia
• bladder leakage

According to one expert, treating these issues is often a initial approach toward sexual wellness.

“When a patient presents with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

The expert suggested both topical estrogen therapy and hormone replacement therapy (HRT) as treatments to alleviate the symptoms of menopause, particularly vaginal dryness.

She expressed hope 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 sometimes used without formal approval to treat reduced desire in women, although it is not indicated for it.

But in addition to drugs, doctors say that personal habits should also be considered. Conversations about sexual desire 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 advise them to talk about some of the psychosocial issues going on,” she said.

Other recommendations for boosting libido are:

• getting more sleep
• exercising
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• practicing extended foreplay
• incorporating vibrators or dilators

“It requires an entire whole body approach to sexual health and menopause in later life,” said an OB-GYN. “This involves knowing how your body works, your anatomy, 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.”