- The FDA expanded its approval of Addyi, a daily drug to address low libido in women, to include postmenopausal women up to age 65.
- This decision will open up additional therapeutic avenues for this demographic, but experts caution that treating low libido requires a “comprehensive strategy.”
- This drug presents potentially dangerous interactions with drinking that may result in syncope, so avoiding alcoholic beverages is strongly advised.
The federal agency broadened the authorized use of a once-a-day medication to treat low libido in females to cover women after menopause up to the age of sixty-five.
Before this week's decision, the medication, Addyi (flibanserin), was solely authorized to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.
The drug was initially cleared by the FDA in two thousand fifteen, following a lengthy and contentious regulatory scrutiny.
Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In each instance, the agency expressed reservations 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 HSDD, though the FDA cleared Vyleesi (bremelanotide), an as-needed injectable treatment, in two thousand nineteen.
The chief executive of the maker of flibanserin applauded the FDA’s decision to expand the drug’s approval, calling it a “landmark event” in understanding and prioritizing female sexual health.
Additional women’s health experts expressed support for the decision.
“Previously, options were limited for me to prescribe because everything was for women who were premenopausal and not menopausal,” said an OB-GYN. “Getting the FDA approval 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 issues with libido.”
A clinical professor told reporters that the approval was “quite reasonable” given the existing research.
While in favor, the expert was measured in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the degree of the enhancement is not dramatic. Is it worthwhile taking a drug every single day and not getting bang for your buck?”
What is Addyi, the ‘Women's Desire Pill’?
Addyi, which is sometimes referred to as “female Viagra,” has little in common with the medication from which it draws its nickname.
The drug was originally developed as an medication for depression but was deemed ineffective during early studies.
However, researchers noted improvements in aspects of libido and arousal and redirected efforts to the drug’s potential as a treatment for diminished sexual desire.
After two rejections, flibanserin was cleared in 2015 to treat HSDD, following further studies and a major advocacy campaign.
The medication carries a boxed (“black box”) warning for severe side effects, including a drop in blood pressure and loss of consciousness, when combined with alcoholic drinks.
Official guidance recommends allowing a two-hour gap after drinking before using the drug to reduce the chance of syncope. If a person consumes three or more alcoholic drinks on a single occasion, the label recommends skipping the dose entirely.
Claims about the effects of mixing Addyi and alcohol eventually prompted the pharmaceutical company to fund further research examining the combination. The research, which were small in scale, showed no increased danger of syncope. But medical professionals had reservations.
“These studies don’t seem very convincing to me. They are a beginning, 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 reason why the drug was not originally approved for postmenopausal women.
“There have been side effects like the syncopal episodes and dizziness especially in individuals who have had an drink within two hours of taking the pill. When you get older, you become more susceptible to things like that,” she said.
Another doctor expressed uncertainty about why the broader approval 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 prescribing,” he said.
Treating Diminished Sexual Desire in Postmenopausal Women
Despite these risks, flibanserin could still expand treatment options for low desire to a new population of females who may benefit.
“I do think it will serve this demographic better as long as they have no other medical problems,” said an OB-GYN.
But it is not a magic bullet. In fact, the experts interviewed all agreed that the women's sexual desire is complex and multifaceted.
So addressing HSDD means considering everything from partnership issues to shifts in hormone levels.
Postmenopausal females experience a wide variety of symptoms that can affect libido. Symptoms of menopause include:
- hot flashes
- lack of natural lubrication
- pain during intercourse
- sleep disturbances
- bladder leakage
As noted by one expert, managing these issues is often a initial approach toward improved intimacy.
“When a patient presents with libido issues, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” she said.
The expert recommended both vaginal estrogen and systemic hormone therapy as options to treat the effects of menopause, particularly vaginal dryness.
She expressed hope that the regulatory decision to lift of its “serious” warning on HRT will lead more females to feel less concerned about it and to view it as a treatment option.
Androgen therapy is also occasionally used without formal approval to address reduced desire in women, although it is not indicated for it.
But besides medication, doctors say that lifestyle should also be considered. Discussions about sexual desire almost always start with relationships and intimacy.
“I would have no problem recommending Addyi after discussing it with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said.
Other suggestions for increasing sexual desire are:
- improving sleep hygiene
- engaging in physical activity
- maintaining an active lifestyle
- using over-the-counter lubricants
- practicing extended foreplay
- using vibrators or vaginal dilators
“It requires an comprehensive, holistic strategy to sexuality and menopause in older age,” 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 excited, and ultimately to have a peak of orgasm.”
