🔗 Share this article FDA Grants Approval to Addyi, a Desire-Boosting Medication for Postmenopausal Flibanserin, sometimes referred to as “female Viagra,” is now approved for use to address low sex drive in women after menopause. The agency widened the authorized use of Addyi, a oral medication to treat low libido in women, to include postmenopausal women up to age 65. The regulatory green light will unlock fresh choices for this demographic, but specialists warn that treating low libido requires a “whole body approach.” The medication carries potentially dangerous interactions with drinking that may cause fainting, so abstinence from alcohol is recommended. The Food and Drug Administration (FDA) broadened the authorized use of a daily pill to manage hypoactive sexual desire disorder (HSDD) in women to include women after menopause up to 65 years old. Before the announcement, the drug, flibanserin (Addyi), was only approved to treat low sexual desire in premenopausal females. The drug was initially cleared by the FDA in 2015, following a protracted and controversial regulatory scrutiny. The FDA previously rejected the drug on two distinct instances, in 2010 and again in 2013. In both cases, the agency expressed reservations about its safety profile, efficacy, and an concerning balance of risks and benefits. Today, Addyi is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared bremelanotide (Vyleesi), an injectable used when desired, in 2019. The founder and CEO of the pharmaceutical company of flibanserin commended the FDA’s move to broaden the drug’s indication, calling it a “significant step” in understanding and prioritizing female sexual health. Other specialists in female health were supportive for the regulatory move. “There was nothing for me to prescribe because everything was for women who were premenopausal and not menopausal,” said an OB-GYN. “Securing the FDA clearance for this group of women could be crucial to address postmenopausal women 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 clinical evidence. While in favor, the expert was cautious in her evaluation: “Clinical trials showed statistical significance of the drug over the inactive pill, but the extent of the benefit is not dramatic. Does it justify taking a drug every single day and not seeing a major effect?” What is Addyi, the ‘Female Viagra’? Addyi, which is sometimes referred to as “the women's version of Viagra,” has significant differences with the drug from which it draws its nickname. This medication was initially researched as an medication for depression but was considered unsuccessful during initial trials. Nevertheless, scientists observed positive changes in measures 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 significant advocacy campaign. Addyi carries a serious safety warning for serious side effects, including low blood pressure (hypotension) and fainting (syncope), when combined with alcohol. Official guidance advises waiting at least two hours after drinking before using the drug to reduce the risk of fainting. If a person has three or more alcoholic drinks on a single occasion, the instructions advises not taking the pill entirely. Assertions about the interactions of mixing the drug with drinking eventually led the pharmaceutical company to fund further research examining the interaction. The research, which were small in scale, showed no increased danger of syncope. But experts had concerns. “This research don’t seem very persuasive to me. They are a good start, but they’re not very big and certainly aren’t very long,” a public health expert stated. An OB-GYN suggested that this may have been part of the cause why Addyi was not initially cleared for older females. “There have been adverse reactions like the syncopal episodes and dizziness especially in persons who have had an alcoholic beverage within two hours of taking the pill. When you get older, you become more susceptible to effects like that,” she said. Another doctor echoed confusion about why the broader approval was limited at 65 years of age. “I don’t know if that has to do with the intricacies 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. Treating Diminished Sexual Desire in Postmenopausal Women Notwithstanding the warnings, Addyi could still expand therapeutic choices for HSDD to a new population of females who may find help. “I do think 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 experts interviewed all agreed that the women's sexual desire is complex and multifaceted. So treating low desire means considering everything from relationship dynamics to shifts in hormone levels. Postmenopausal females experience a wide variety of changes that can impact sexual desire. Symptoms of menopause encompass: sudden feelings of heat vaginal dryness discomfort with sex sleep disturbances urinary incontinence As noted by one expert, treating these issues is often a first step toward sexual wellness. “If somebody came to me with libido issues, my initial inquiry is: How’s your vagina feeling? Are you comfortable?” she said. The expert suggested both vaginal estrogen and hormone replacement therapy (HRT) as options to treat the symptoms 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 consider it as a treatment option. Testosterone is also sometimes prescribed off-label to address reduced desire in women, although it is not officially approved for it. But in addition to drugs, experts say that lifestyle should also be factored in. Discussions about sexual desire almost always start with partnership dynamics and closeness. “I am comfortable 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 suggestions for increasing libido are: improving sleep hygiene engaging in physical activity staying active applying over-the-counter lubricants engaging in extended intimate stimulation incorporating vibrators or vaginal dilators “It requires an entire whole body approach to sexual health and menopause in later life,” said an expert. “That means knowing how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of orgasm.”