FDA Grants Approval to Addyi, a Libido-Enhancing Drug for Women After Menopause

The Food and Drug Administration (FDA) expanded its approval of a daily pill to address hypoactive sexual desire disorder (HSDD) in females to now encompass postmenopausal women up to age 65.

Prior to the recent news, the drug, Addyi (flibanserin), 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 protracted and controversial review process.

Regulators had earlier turned down the drug on two separate occasions, in 2010 and again in 2013. In each instance, the agency cited issues about safety, effectiveness, and an concerning balance of risks and benefits.

Now, flibanserin is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an on-demand injection, in two thousand nineteen.

The chief executive of the maker of Addyi praised the FDA’s move to broaden the drug’s approval, calling it a “milestone” in understanding and prioritizing female sexual health.

Other OB-GYNs voiced approval for the regulatory move.

“I had few tools for me to prescribe because everything was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be significant to help women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told reporters that the decision was “quite reasonable” given the existing research.

Although supportive, the expert was cautious in her assessment: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the degree of the improvement is not dramatic. Does it justify taking a drug every single day and not seeing a major effect?”

What is Addyi, the ‘Women's Desire Pill’?

Addyi, which is often called “female Viagra,” has significant differences with the drug from which it gets its informal name.

The drug was first created as an medication for depression but was deemed ineffective during initial trials.

However, researchers noted positive changes in aspects of sexual function and redirected efforts to the drug’s potential as a therapy for diminished sexual desire.

Following initial denials, Addyi was approved in 2015 to treat HSDD, following additional research and a considerable advocacy campaign.

The medication carries a boxed (“black box”) warning for severe adverse reactions, including a drop in blood pressure and fainting (syncope), when combined with alcohol.

Official guidance recommends waiting at least two hours after drinking before taking Addyi to reduce the risk of fainting. If a person consumes three or more alcoholic drinks on a single occasion, the instructions advises skipping the dose entirely.

Claims about the interactions of combining Addyi and alcohol eventually led the pharmaceutical company to fund further research examining the interaction. The studies, which were small in scale, demonstrated no increased danger of fainting. But experts had concerns.

“This research aren't very persuasive to me. They are a beginning, but they’re not very big and certainly are short-term,” a health research president stated.

An gynecologist speculated that this may have been part of the reason why the drug was not originally approved for older females.

“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 expressed uncertainty about why the broader approval was capped at 65 years of age.

“It's unclear if that has to do with the complexity of the medication. Reviewing 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 easier information sheet because it may affect our prescribing,” he said.

Treating Low Libido After Menopause

Despite these risks, flibanserin could still broaden therapeutic choices for HSDD to a different group of women who may benefit.

“I believe it will serve this demographic better as long as they have no other medical problems,” said an specialist.

But it is not a simple solution. In fact, the experts consulted all agreed that the female libido is complex and multifaceted.

So treating HSDD means considering everything from partnership issues to hormonal changes.

Postmenopausal females experience a broad range of symptoms that can impact libido. Symptoms of menopause include:

• hot flashes
• vaginal dryness
• discomfort with sex
• sleep disturbances
• urinary incontinence

As noted by one expert, managing these issues is often a first step toward improved intimacy.

“When a patient presents with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

The expert recommended both topical estrogen therapy and systemic hormone therapy as options to alleviate the symptoms of menopause, particularly dryness.

She hopes that the regulatory decision to lift of its “serious” warning on hormone therapy will lead more women to feel less apprehensive about it and to consider it as a treatment option.

Testosterone is also occasionally prescribed off-label to address low libido in women, although it is not indicated for it.

But besides medication, experts say that lifestyle should also be considered. Conversations about sexual desire almost always start with partnership dynamics and closeness.

“I would have no problem recommending Addyi after having a conversation with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Additional suggestions for boosting sexual desire include:

• improving sleep hygiene
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• engaging in extended intimate stimulation
• incorporating vibrators or dilators

“You have to take an comprehensive, holistic strategy to sexual health and menopause in older age,” said an OB-GYN. “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 orgasm.”