🔗 Share this article FDA Grants Approval to Addyi, a Libido-Enhancing Medication for Postmenopausal Flibanserin, colloquially known as “the women's Viagra,” is now cleared for treatment to treat reduced sexual desire in postmenopausal women. The FDA expanded its approval of flibanserin, a pill to address low libido in women, to encompass postmenopausal women up to age 65. This decision will open up additional therapeutic avenues for older women, but experts caution that treating low libido requires a “holistic method.” The medication carries potentially dangerous interactions with alcohol that may lead to fainting, so abstinence from alcohol is strongly advised. The federal agency widened the indication of a once-a-day medication to manage low libido in females to include postmenopausal women up to the age of sixty-five. Before the recent news, the drug, flibanserin (Addyi), was solely authorized to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age. This medication was initially cleared by the FDA in 2015, following a long and debated regulatory scrutiny. Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In each instance, the agency expressed reservations about safety, efficacy, and an unfavorable risk–benefit profile. Today, Addyi is the sole oral drug cleared by the FDA for HSDD, though the FDA approved bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen. The founder and CEO of the maker of Addyi commended the FDA’s move to expand the drug’s approval, calling it a “landmark event” in understanding and prioritizing women's sexual wellness. Other specialists in female health were supportive for the decision. “Previously, options were limited for me to prescribe because available treatments was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Getting the FDA clearance for this patient population could be significant to address women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.” A clinical professor told reporters that the approval was “quite reasonable” given the available data. Although supportive, the expert was measured in her assessment: “Clinical trials showed statistical significance of the drug over the placebo, but the degree of the improvement is not dramatic. Does it justify taking a drug every single day and not seeing a major effect?” Understanding Flibanserin, the ‘Women's Desire Pill’? Addyi, which is sometimes referred to as “female Viagra,” has little in common with the drug from which it gets its informal name. The drug was initially researched as an antidepressant but was found to be lacking during initial trials. Nevertheless, scientists observed improvements in aspects of libido and arousal and redirected efforts to the drug’s potential as a treatment for diminished sexual desire. Following initial denials, flibanserin was approved in 2015 to treat HSDD, following further studies and a major lobbying effort. Addyi carries a boxed (“black box”) warning for severe side effects, including a drop in blood pressure and fainting (syncope), when combined with alcohol. The label recommends allowing a two-hour gap after drinking before using Addyi to minimize the chance of fainting. If a person consumes three or more alcoholic drinks on a given day, the label recommends not taking the pill entirely. Claims about the interactions of mixing Addyi and alcohol eventually led the maker to fund additional studies examining the interaction. The studies, which were limited in size, showed no increased danger of fainting. But medical professionals had reservations. “These studies don’t seem 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 OB-GYN suggested that this may have been part of the cause why Addyi was not initially cleared for postmenopausal women. “There have been adverse reactions like the fainting spells and lightheadedness especially in individuals who have had an drink within two hours of treatment. When you get more advanced in age, you become more susceptible to things like that,” she said. Another doctor expressed confusion about why the expanded indication was limited at 65 years of age. “I don’t know if that has to do with the complexity of the drug. If you take a list of the dos and don’ts, it’s really wide-ranging. Now that this has been approved, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said. Addressing Diminished Sexual Desire in Postmenopausal Women Notwithstanding the warnings, flibanserin could still expand treatment options for HSDD 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 magic bullet. In fact, the specialists consulted universally acknowledged that the female libido is complex and multifaceted. So treating low desire means engaging with everything from partnership issues to hormonal changes. Postmenopausal females navigate a wide variety of changes that can affect libido. Symptoms of menopause include: hot flashes lack of natural lubrication discomfort with sex insomnia bladder leakage According to one expert, managing these symptoms is often a first step 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 recommended both vaginal estrogen and hormone replacement therapy (HRT) as options to alleviate the effects of menopause, particularly dryness. She hopes that the FDA’s recent removal of its “black box” warning on hormone therapy will lead more women to feel less apprehensive about it and to view it as a treatment option. Testosterone is also sometimes used without formal approval to treat low libido in females, although it is not indicated for it. But besides medication, doctors say that personal habits should also be considered. Conversations about sexual desire almost always begin by focusing on relationships and intimacy. “I am comfortable 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 suggestions for increasing libido are: improving sleep hygiene engaging in physical activity staying active using over-the-counter lubricants practicing extended intimate stimulation using vibrators or dilators “It requires an comprehensive, holistic strategy to sexual health and this life stage in later life,” said an expert. “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 climax of sexual pleasure.”