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U.S. regulators expanded its approval of a once-a-day medication to address hypoactive sexual desire disorder (HSDD) in females to now encompass women after menopause up to age 65.

Before this week's decision, the pill, Addyi (flibanserin), was exclusively cleared to treat low sexual desire in premenopausal females.

This medication was originally authorized by the FDA in two thousand fifteen, following a protracted and controversial review process.

Regulators had earlier turned down the drug on two separate occasions, in 2010 and 2013. In each instance, the agency raised concerns about safety, efficacy, and an unfavorable risk–benefit profile.

Currently, Addyi is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

The founder and CEO of the maker of flibanserin commended the FDA’s move to broaden the drug’s approval, calling it a “significant step” in advancing and focusing on women's sexual wellness.

Additional OB-GYNs expressed support for the regulatory move.

“I had few tools for me to recommend because everything was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this patient population could be crucial to help postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the approval was “understandable” given the clinical evidence.

Although supportive, the expert was cautious in her evaluation: “Clinical trials showed statistical significance of the drug over the inactive pill, but the magnitude of the benefit is not substantial. Does it justify taking a drug daily and not getting bang for your buck?”

Understanding Addyi, the ‘Female Viagra’?

Addyi, which is often called “female Viagra,” has significant differences 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 noted positive changes in aspects of libido and arousal and redirected efforts to the drug’s possible use as a treatment for low libido.

After two rejections, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a major advocacy campaign.

The medication carries a boxed (“black box”) warning for potentially dangerous adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcohol.

Official guidance recommends allowing a two-hour gap after consuming alcohol before taking Addyi to minimize the chance of syncope. If a person has three or more alcoholic drinks on a given day, the instructions advises skipping the dose entirely.

Claims about the interactions of mixing Addyi and alcohol eventually led the maker to fund further research examining the combination. The studies, which were limited in size, showed no increased danger of fainting. But medical professionals had reservations.

“This research 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 gynecologist speculated that this may have been part of the cause why the drug was not originally approved for postmenopausal women.

“There have been adverse reactions like the syncopal episodes and lightheadedness especially in individuals 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 confusion about why the broader approval was limited at age 65.

“It's unclear if that has to do with the complexity of the medication. If you take a list of the dos and don’ts, it’s really wide-ranging. 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, flibanserin could still broaden therapeutic choices for low desire to a new population of females who may find help.

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

But it is not a simple solution. In fact, the specialists interviewed all agreed that the women's sexual desire is complex and multifaceted.

So treating low desire means considering everything from partnership issues to hormonal changes.

Postmenopausal females experience a wide variety of symptoms that can affect libido. Symptoms of menopause encompass:

• hot flashes
• lack of natural lubrication
• pain during intercourse
• insomnia
• urinary incontinence

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

“When a patient presents 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 vaginal dryness.

She expressed hope that the FDA’s recent removal of its “black box” warning on HRT will lead more females to feel less concerned about it and to view it as a viable choice.

Testosterone is also sometimes used without formal approval to address low libido in females, although it is not indicated for it.

But in addition to drugs, experts say that lifestyle should also be factored in. Conversations about libido almost always start with relationships and intimacy.

“I am comfortable recommending Addyi after discussing it with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said.

Additional suggestions for increasing sexual desire include:

• improving sleep hygiene
• exercising
• staying active
• using over-the-counter lubricants
• practicing extended intimate stimulation
• incorporating vibrators or dilators

“It requires an comprehensive, holistic strategy to sexual health and this life stage in older age,” said an OB-GYN. “That means 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.”