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U.S. regulators expanded its approval of a oral treatment to treat low libido in women to include women after menopause up to 65 years old.

Before the recent news, the drug, Addyi (flibanserin), was only approved to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

The drug was initially cleared by the FDA in 2015, following a lengthy and contentious review process.

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In both cases, the agency cited issues about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Now, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in two thousand nineteen.

The founder and CEO of the maker of Addyi commended the FDA’s move to expand the drug’s indication, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Additional OB-GYNs were supportive for the decision.

“There was nothing for me to prescribe because everything was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this patient population could be crucial to address postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told reporters that the approval was “understandable” given the existing research.

While in favor, the expert was measured in her assessment: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the magnitude of the enhancement is not substantial. Is it worthwhile taking a drug every single day and not getting bang for your buck?”

Understanding Addyi, the ‘Women's Desire Pill’?

Addyi, which is sometimes referred to as “female Viagra,” has significant differences with the drug from which it gets its informal name.

The drug was first created as an antidepressant but was deemed ineffective during initial trials.

However, scientists observed positive changes in aspects of sexual function and redirected efforts to the drug’s possible use as a therapy for low libido.

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

Addyi carries a serious safety warning for severe adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcohol.

The label recommends allowing a two-hour gap after drinking before using the drug to minimize the chance of syncope. If a person consumes three or more alcoholic drinks on a given day, the label advises skipping the dose entirely.

Assertions about the effects of mixing the drug with drinking eventually prompted the pharmaceutical company to fund further research examining the interaction. The research, which were small in scale, demonstrated no increased danger of syncope. But experts had concerns.

“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 gynecologist speculated that this may have been part of the cause why Addyi was not initially cleared 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 older, you become more susceptible to effects like that,” she said.

Another doctor expressed uncertainty about why the broader approval was limited at 65 years of age.

“I don’t know if that has to do with the complexity of the medication. Reviewing 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 prescribing,” he said.

Treating Low Libido in Postmenopausal Women

Notwithstanding the warnings, Addyi could still expand therapeutic choices for HSDD 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 OB-GYN.

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

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

Postmenopausal females navigate a broad range of changes that can affect libido. Menopausal symptoms include:

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

As noted by one expert, treating these issues is often a first step 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 vaginal estrogen and hormone replacement therapy (HRT) as treatments to alleviate the effects of menopause, particularly dryness.

She hopes that the regulatory decision to lift of its “black box” warning on hormone therapy will lead more females to feel less apprehensive about it and to consider it as a viable choice.

Androgen therapy is also occasionally used without formal approval to treat low libido in females, although it is not indicated for it.

But besides medication, doctors say that lifestyle should also be factored in. Conversations about libido almost always start with relationships and intimacy.

“I would have no problem recommending 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.

Other recommendations for boosting libido are:

• getting more sleep
• engaging in physical activity
• staying active
• applying over-the-counter lubricants
• practicing extended intimate stimulation
• incorporating vibrators or dilators

“You have to take an entire whole body approach to sexual health and menopause in older age,” said an OB-GYN. “This involves knowing how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of orgasm.”