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U.S. regulators expanded its approval of a daily pill to address low libido in women to cover postmenopausal women up to the age of sixty-five.

Prior to this week's decision, the pill, Addyi (flibanserin), was solely authorized to address low sexual desire in women of reproductive age.

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

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

Currently, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

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

Other OB-GYNs voiced approval for the decision.

“There was nothing for me to recommend because available treatments was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this patient population could be very important to help women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

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

Although supportive, the expert was cautious in her evaluation: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the extent of the enhancement is not substantial. Does it justify taking a drug daily and not seeing a major effect?”

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

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

The drug was first created as an antidepressant but was considered unsuccessful during early studies.

However, scientists observed positive changes in aspects of libido and arousal and shifted focus to the drug’s potential as a treatment for diminished sexual desire.

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

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 waiting at least two hours after drinking before taking Addyi to minimize the chance of fainting. If a person has several drinks on a given day, the instructions recommends not taking the pill entirely.

Assertions about the effects of combining Addyi and alcohol eventually led the pharmaceutical company to fund further research investigating the combination. The studies, which were small in scale, showed no additional risk of syncope. But medical professionals had reservations.

“This research don’t seem very persuasive to me. They are a beginning, but they’re not very large-scale and certainly are short-term,” a health research president stated.

An OB-GYN suggested that this may have been part of the reason why the drug was not originally approved for older females.

“Patients have experienced side effects like the fainting spells and dizziness especially in persons who have had an drink within two hours of treatment. When you get older, you become more susceptible to effects like that,” she said.

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

“It's unclear if that has to do with the complexity of the medication. If you take 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 simpler guidance because it may affect our prescribing,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

Despite these risks, flibanserin could still expand treatment options for low desire to a different group of females who may benefit.

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

But it is not a simple solution. In fact, the experts interviewed all agreed that the women's sexual desire is influenced by many factors.

So addressing low desire means considering everything from partnership issues to shifts in hormone levels.

Women after menopause experience a broad range of changes that can impact sexual desire. Menopausal symptoms encompass:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• urinary incontinence

According to one expert, managing these issues is often a initial approach toward improved intimacy.

“If somebody came to me with concerns about desire, my first question is: How’s your vagina feeling? Are you comfortable?” she said.

The expert suggested both vaginal estrogen and systemic hormone therapy as treatments to alleviate 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 apprehensive about it and to consider it as a treatment option.

Androgen therapy is also occasionally used without formal approval to address reduced desire in women, although it is not officially approved for it.

But besides medication, doctors say that lifestyle should also be considered. Conversations about libido almost always begin by focusing on partnership dynamics and closeness.

“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 psychosocial issues going on,” she said.

Additional recommendations for increasing libido include:

• getting more sleep
• engaging in physical activity
• staying active
• using over-the-counter lubricants
• practicing extended foreplay
• incorporating vibrators or vaginal dilators

“It requires an comprehensive, holistic strategy to sexual health and menopause in later life,” said an OB-GYN. “This involves understanding 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.”