🔗 Share this article FDA Grants Approval to Flibanserin, a Desire-Boosting Treatment for Postmenopausal Addyi, sometimes referred to as “female Viagra,” is now approved for use to address diminished libido in postmenopausal women. The FDA expanded its approval of flibanserin, a daily drug to address low libido in women, to encompass women after menopause up to age 65. The regulatory green light will open up fresh choices for this demographic, but specialists warn that addressing HSDD requires a “whole body approach.” Addyi is known to have potentially dangerous interactions with alcohol that may result in loss of consciousness, so abstinence from alcohol is strongly advised. U.S. regulators expanded its approval of a daily pill to manage low libido in women to include women after menopause up to age 65. Prior to this week's decision, the medication, Addyi (flibanserin), was solely authorized to treat low sexual desire in women of reproductive age. The drug was initially cleared by the FDA in two thousand fifteen, following a lengthy and contentious regulatory scrutiny. The agency had denied approval for 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, flibanserin is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in two thousand nineteen. The chief executive of the maker of Addyi praised the FDA’s action to expand the drug’s indication, calling it a “landmark event” in understanding and prioritizing female sexual health. Additional specialists in female health were supportive for the regulatory move. “I had few tools for me to prescribe because available treatments was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this group of women could be crucial to help women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.” A professor of obstetrics and gynecology told reporters that the decision was “logical” given the available data. While in favor, the expert was measured in her assessment: “Clinical trials showed statistical significance of the drug over the placebo, but the extent of the enhancement is not overwhelming. Does it justify taking a drug daily and not seeing a major effect?” Understanding Addyi, the ‘Female Viagra’? Flibanserin, which is often called “the women's version of Viagra,” has significant differences with the medication from which it gets its informal name. This medication was initially researched as an antidepressant but was considered unsuccessful during initial trials. Nevertheless, scientists noted improvements in aspects of sexual function and shifted focus to the drug’s possible use as a therapy for low libido. Following initial denials, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a significant lobbying effort. The medication carries a boxed (“black box”) warning for serious adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcoholic drinks. Official guidance recommends waiting at least two hours after drinking before taking the drug to reduce the chance of syncope. If a person consumes several drinks on a single occasion, the instructions recommends skipping the dose entirely. Assertions about the effects of mixing Addyi and alcohol eventually prompted the pharmaceutical company to fund additional studies investigating the interaction. The research, which were small in scale, demonstrated no increased danger of fainting. But medical professionals had reservations. “These studies aren't very convincing to me. They are a beginning, but they’re not very large-scale and certainly aren’t very long,” a public health expert stated. An gynecologist speculated that this may have been part of the reason why the drug was not initially cleared for postmenopausal women. “There have been side effects like the fainting spells and lightheadedness especially in individuals who have had an alcoholic beverage within two hours of treatment. When you get more advanced in age, you become more sensitive to effects like that,” she said. Another doctor expressed confusion about why the expanded indication was capped at age 65. “I don’t know if that has to do with the complexity of the drug. If you take a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been cleared, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said. Addressing Low Libido After Menopause Despite these risks, Addyi could still expand treatment options for HSDD to a different group of females who may find help. “I believe 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 specialists interviewed all agreed that the female libido is complex and multifaceted. So addressing HSDD means engaging with everything from relationship dynamics to hormonal changes. Postmenopausal females experience a broad range of changes that can impact sexual desire. Menopausal symptoms include: sudden feelings of heat lack of natural lubrication discomfort with sex insomnia bladder leakage As noted by one expert, treating these issues is often a initial approach toward sexual wellness. “When a patient presents with concerns about desire, my first question is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said. The expert suggested both vaginal estrogen and hormone replacement therapy (HRT) as treatments to alleviate the effects of menopause, particularly dryness. She expressed hope that the regulatory decision to lift of its “serious” warning on hormone therapy 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 address reduced desire in women, although it is not officially approved for it. But besides medication, experts say that personal habits should also be considered. Conversations about sexual desire almost always start with relationships and intimacy. “I am comfortable recommending 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. Other suggestions for increasing libido include: getting more sleep exercising staying active applying over-the-counter lubricants practicing extended intimate stimulation incorporating sexual wellness devices or dilators “It requires an entire whole body approach to sexuality and menopause in later life,” said an expert. “That means knowing how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of sexual pleasure.”