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U.S. regulators expanded its approval of a once-a-day medication to manage hypoactive sexual desire disorder (HSDD) in females to include postmenopausal women up to 65 years old.

Before the announcement, the medication, Addyi (flibanserin), was exclusively cleared to address low sexual desire in premenopausal females.

This medication was first approved by the FDA in 2015, following a lengthy and contentious regulatory scrutiny.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In both cases, the agency raised concerns about its safety profile, efficacy, and an concerning balance of risks and benefits.

Now, Addyi is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in 2019.

The founder and CEO of the pharmaceutical company of flibanserin praised the FDA’s move to broaden the drug’s approval, calling it a “milestone” in understanding and prioritizing women's sexual wellness.

Other specialists in female health were supportive for the decision.

“Previously, options were limited for me to recommend because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this patient population could be very important to help postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the approval was “quite reasonable” given the clinical evidence.

Although supportive, the expert was measured in her assessment: “The studies showed a meaningful difference of the drug over the placebo, but the degree of the enhancement is not dramatic. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”

What is Addyi, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “female Viagra,” has few similarities with the medication from which it draws its nickname.

The drug was first created as an antidepressant but was considered unsuccessful during initial trials.

However, researchers observed improvements in measures of sexual function and redirected efforts to the drug’s potential as a treatment for diminished sexual desire.

Following initial denials, Addyi was cleared in 2015 to treat HSDD, following additional research and a major lobbying effort.

Addyi carries a serious safety warning for severe side effects, including a drop in blood pressure and loss of consciousness, when combined with alcoholic drinks.

The label recommends allowing a two-hour gap after drinking before taking Addyi to reduce the chance of syncope. If a person has several drinks on a single occasion, the instructions advises not taking the pill entirely.

Claims about the effects of combining Addyi and alcohol eventually prompted the pharmaceutical company to fund further research examining the combination. The research, which were limited in size, showed no increased danger of syncope. But experts had reservations.

“These studies aren't very persuasive to me. They are a beginning, 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 reason why Addyi was not originally approved for postmenopausal women.

“There have been adverse reactions like the fainting spells and dizziness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get more advanced in age, you become more susceptible to effects like that,” she said.

Another doctor echoed confusion about why the expanded indication was limited 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 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 do think it will benefit this demographic better as long as they have no other medical problems,” said an specialist.

But it is not a magic bullet. In fact, the experts interviewed universally acknowledged that the women's sexual desire is influenced by many factors.

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

Postmenopausal females navigate a wide variety of symptoms that can affect sexual desire. Symptoms of menopause include:

• hot flashes
• vaginal dryness
• discomfort with sex
• sleep disturbances
• bladder leakage

As noted by one expert, managing these issues is often a initial approach toward sexual wellness.

“If somebody came to me with libido issues, my first question 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 effects of menopause, particularly dryness.

She hopes that the FDA’s recent removal of its “serious” warning on hormone therapy will lead more females to feel less concerned about it and to view it as a viable choice.

Androgen therapy is also sometimes prescribed off-label to address low libido 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 libido almost always start with relationships and intimacy.

“I would have no problem prescribing flibanserin after discussing it with a patient. But I would also encourage 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
• engaging in physical activity
• staying active
• applying over-the-counter personal lubricants
• practicing extended intimate stimulation
• incorporating vibrators or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexual health and this life stage in older age,” said an OB-GYN. “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.”