🔗 Share this article FDA Grants Approval to Flibanserin, a Desire-Boosting Treatment for Females Beyond Menopause Flibanserin, sometimes referred to as “the women's Viagra,” is now approved for use to combat low sex drive in postmenopausal women. The FDA expanded its approval of Addyi, a daily drug to treat low libido in women, to encompass women after menopause up to age 65. The approval will provide additional therapeutic avenues for this demographic, but specialists warn that addressing HSDD requires a “holistic method.” The medication carries serious risks with drinking that may cause syncope, so avoiding alcoholic beverages is recommended. U.S. regulators expanded its approval of a once-a-day medication to manage hypoactive sexual desire disorder (HSDD) in females to cover women after menopause up to 65 years old. Before the announcement, the drug, flibanserin (Addyi), was only approved to treat hypoactive sexual desire disorder (HSDD) in premenopausal females. Flibanserin was originally authorized by the FDA in two thousand fifteen, following a long and debated review process. The agency had denied approval for the drug on two distinct instances, in 2010 and again in 2013. In each instance, 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 hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an injectable used when desired, in 2019. The chief executive of the pharmaceutical company of flibanserin applauded the FDA’s move to expand the drug’s indication, calling it a “landmark event” in advancing and focusing on women's sexual wellness. Other specialists in female health voiced approval for the regulatory move. “There was nothing for me to prescribe because available treatments was for women who were menstrual 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 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 evaluation: “The studies showed a meaningful difference of the drug over the inactive pill, but the magnitude of the enhancement is not substantial. Does it justify taking a drug daily and not experiencing a dramatic change?” Understanding Addyi, the ‘Women's Desire Pill’? Flibanserin, 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 originally developed as an antidepressant but was considered unsuccessful during initial trials. However, scientists observed positive changes in measures of sexual function and redirected efforts to the drug’s possible use as a therapy for diminished sexual desire. After two rejections, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a considerable lobbying effort. Addyi carries a serious safety warning for serious adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when combined with alcohol. The label advises allowing a two-hour gap after drinking before using the drug to reduce the chance of fainting. If a person consumes three or more alcoholic drinks on a single occasion, the label recommends skipping the dose entirely. Assertions about the effects of mixing the drug with drinking eventually led the pharmaceutical company to fund further research examining the combination. The studies, which were small in scale, showed no increased danger of fainting. But experts had concerns. “This research don’t seem very persuasive to me. They are a good start, but they’re not very large-scale and certainly are short-term,” 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. “Patients have experienced side effects like the syncopal episodes and dizziness especially in individuals 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 uncertainty about why the expanded indication was limited at 65 years of age. “It's unclear if that has to do with the complexity of the drug. 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. Addressing Low Libido After Menopause Despite these risks, flibanserin could still expand therapeutic choices for low desire to a different group of women who may find help. “I believe it will serve this population better as long as they have no other medical problems,” said an OB-GYN. But it is not a quick fix. In fact, the specialists consulted universally acknowledged that the female libido is influenced by many factors. So addressing low desire means considering everything from relationship dynamics to shifts in hormone levels. Postmenopausal females experience a broad range of symptoms that can impact sexual desire. Symptoms of menopause include: hot flashes vaginal dryness pain during intercourse insomnia urinary incontinence As noted by one expert, treating these symptoms is often a initial approach 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 recommended both topical estrogen therapy and systemic hormone therapy as options to alleviate the effects of menopause, particularly vaginal dryness. She hopes that the FDA’s recent removal of its “serious” warning on HRT will lead more women to feel less apprehensive about it and to consider it as a viable choice. Testosterone is also occasionally used without formal approval to address reduced desire in females, although it is not indicated for it. But besides medication, doctors say that lifestyle should also be considered. Discussions about libido almost always begin by focusing on relationships and intimacy. “I would have no problem prescribing Addyi after having a conversation with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said. Additional recommendations for increasing sexual desire include: improving sleep hygiene exercising maintaining an active lifestyle using over-the-counter personal lubricants practicing extended foreplay using vibrators or vaginal dilators “You have to take an comprehensive, holistic strategy to sexual health and this life stage in later life,” said an expert. “That means understanding how your body works, your anatomy, and your sexual needs — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of sexual pleasure.”