Pam Harrison

November 05, 2016

For women with hypoactive sexual desire disorder, flibanserin (Addyi) can improve both sexual and nonsexual symptoms, report researchers at the Sexual Medicine Society of North America Fall 2016 Scientific Meeting in Scottsdale, Arizona.

Flibanserin can be "life-changing in multiple dimensions," said Sue Goldstein, a certified sexuality educator and clinical research manager at San Diego Sexual Medicine.

A diagnosis of hypoactive sexual desire disorder can be made when a woman's sexual desire was once normal but has waned, and it bothers her and she wants to do something about it, Goldstein told Medscape Medical News.

"The provider needs to determine whether the hypoactive sexual desire disorder is primary or secondary, and a result of something else, like a medication, which could potentially be changed, or a life event, like childbirth, or independent of other issues," she explained.

Unlike testosterone, flibanserin is not a hormone. It appears to work by regulating an imbalance in the brain, simultaneously increasing excitation and decreasing inhibition. This allows "the woman to return to where she was when she was sexually healthy," Goldstein pointed out.

"As for side effects, they are similar to other central nervous system drugs, like bupropion, that have been prescribed for years," she said.

Boxed Warning

The US Food and Drug Administration placed a boxed warning on the flibanserin label about the concurrent consumption of alcohol causing hypotension and syncope.

However, Goldstein pointed out that this warning was based on an alcohol test conducted in the morning, when patients might have been particularly susceptible to the effects of alcohol, especially if taken on an empty stomach.

"The most common side effect of the drug is somnolence, which is why it is dosed at bedtime," she said. "We have not had any complaints of anything other than sleep issues from our patients on the drug."

In their study, Goldstein and her colleagues assessed 130 women from the San Diego Sexual Medicine clinic who were prescribed flibanserin for hypoactive sexual desire disorder.

The women shared their experiences with the medication by email, and 39 testimonials were available for analysis. Mean time on flibanserin was 4 months.

On average, the women reported an improvement in symptoms at 6 weeks. However, time to a positive change in symptoms ranged from just 10 days to 16 weeks, Goldstein reported.

The women said that they experienced increases in sexual responsiveness and sexual thoughts and dreams, and that they were more likely to initiate sex. They also found it easier to articulate their sexual desires to their partner.

Sexual inhibition was also decreased in women with post-traumatic stress disorder related to physical or emotional abuse, some sort of trauma, or painful experiences from previous sexual encounters.

The women who responded to flibanserin said that they were aroused either more quickly or more intensely, that they had more or stronger orgasms, and that, overall, sexual satisfaction was enhanced.

Along with positive changes in symptoms of hypoactive sexual desire disorder, the women also reported that relationships with their partners had improved and that they had experienced positive changes in mood, including feeling like they were having more fun and feeling more alive. General levels of happiness also improved.

"In addition, most respondents lost several pounds of weight and most slept better," said Goldstein.

No serious adverse events were reported by any of the women.

Weight Loss With Flibanserin

Weight loss was shown in women treated with flibanserin in results presented by James Simon, MD, from the George Washington University School of Medicine in Washington, DC.

Three double-blind placebo-controlled studies of flibanserin involved premenopausal and postmenopausal women.

For premenopausal women, weight loss was greater in the flibanserin group than in the placebo group after 24 weeks of treatment (1.4 kg vs 0.1 kg).

The same pattern was seen for postmenopausal women (1.8 kg vs 0.1 kg).

Changes in weight remained relatively stable during 18 months of treatment, but about one-quarter of the women in the flibanserin group lost at least 5% of their baseline body weight.

Other medications approved specifically for weight loss have central nervous system effects that are, at least in part, similar to the effects produced by flibanserin, Dr Simon explained.

"For example, bupropion is a key constituent, along with naltrexone, in the weight-loss product Contrave, and it has a positive effect on sexual function as well," Dr Simon told Medscape Medical News.

Although this mechanism alone is not enough to explain the full effects of flibanserin on weight loss and sexual desire, flibanserin appears to modulate a number of neurotransmitters, ultimately increasing sexual desire, he said.

Concerns about reduced sexual desire are perhaps the most common sexuality-related problems expressed by women seen in gynecology practices today, said Andrew Kaunitz, MD, professor of obstetrics and gynecology at the University of Florida College of Medicine in Jacksonville.

"I think it's fair to say that compared with placebo, the effectiveness of flibanserin is modest for reduced sexual desire in women," Dr Kaunitz told Medscape Medical News. "But among responders, I think we're seeing that there is appreciation for its benefits, particularly given that we don't have other prescription medications to address this issue."

Pivotal clinical trials of flibanserin have indicated that 40% to 60% of women treated for hypoactive sexual desire disorder respond to treatment.

Irwin Goldstein, MD, husband of Sue Goldstein, is a member of the Valeant Scientific Advisory Board, and the couple has received a grant for future research, and both have received a research grant from Palatin. Dr Simon reports financial relationships with AbbVie, Allergan, AMAG Pharmaceuticals, Amgen, Apotex, Ascend Therapeutics, Azure Biotech, Eisai, JDS Therapeutics, Merck, Millendo Therapeutics, Noven Pharmaceuticals, Novo Nordisk, Nuelle, Perrigo Company, Radius Health, Regeneron Pharmaceuticals, Roivant Sciences, Sanofi, Sermonix Pharmaceuticals, Shionogi, Sprout Pharmaceuticals, Symbiotec Pharmalab, TherapeuticsMD, and Valeant Pharmaceuticals. Dr Kaunitz reports serving as a consultant for the Actavis Group, Bayer, Merck, and Teva.

Sexual Medicine Society of North America (SMSNA) Fall 2016 Scientific Meeting: Abstract 239 and 226. Presented November 5, 2016.

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