Flibanserin Enhances Overall Sexual Function in Women with HSDD, Showing Early and Sustained Benefits: Study

Previous studies have shown that flibanserin treatment enhances sexual desire and satisfying sexual experiences while also reducing distress in some women with acquired, generalized hypoactive sexual desire disorder. However, the effects on other aspects of sexual function and the detailed timeline of response have yet to be fully explored. To fill this knowledge gap, Noel N. Kim, Institute for Sexual Medicine, San Diego, CA, USA, and colleagues aimed to assess changes in sexual function, as measured by the subdomains of the Female Sexual Function Index (FSFI), in women with HSDD undergoing treatment with flibanserin.

For the study, FSFI data from three pivotal trials involving premenopausal women treated with flibanserin (n=1,165) or placebo (n=1,203), as well as data from a complete trial involving postmenopausal women (flibanserin n=432; placebo n=463), were analyzed post-hoc.

The analysis focused on changes in FSFI subdomains, with least squares mean change from baseline calculated for each assessment visit at weeks 4, 8, 16, and 24. Treatment groups were compared using analysis of covariance, and standardized effect sizes (Cohen's d) were determined for each subdomain to evaluate the impact of treatment.

The study led to the following findings:

• Compared to placebo, both premenopausal and postmenopausal patients in the flibanserin group reported significantly greater increases over baseline in the FSFI subdomain scores of desire, arousal, lubrication, orgasm, and satisfaction.
• In premenopausal patients, significant improvements were observed at the first assessment of response (week 4) and were maintained through week 24.
• In postmenopausal patients, significant improvements were observed at week 4 for desire and arousal, while significant improvements in lubrication, orgasm, and satisfaction were observed at week 8.
• At week 24, excluding the pain subdomain, standardized effect sizes ranged from 0.18 to 0.28 in the premenopausal cohort and 0.12 to 0.29 in the postmenopausal cohort.
• In both pre- and postmenopausal patients, improvements in pain were smaller and largely undifferentiated between treatment groups.

The researchers conducted sexual function assessments in a substantial cohort of 2,368 premenopausal women and 895 postmenopausal women, a notable strength of the study. However, they acknowledged that the Female Sexual Function Index (FSFI) evaluates changes over one month, limiting the ability to assess time points earlier than four weeks.

According to the authors, although variations in time to response should be considered, flibanserin generally shows a beneficial impact on overall sexual function within the first month of treatment. The data also indicate that this positive response is maintained throughout treatment.

"These analyses indicate that evaluating the benefits of flibanserin for hypoactive sexual desire disorder (HSDD) should encompass improvements across all domains of sexual function, rather than focusing solely on sexual desire," the researchers concluded.

Reference:

Simon, J. A., Clayton, A. H., Goldstein, I., Kingsberg, S. A., Shapiro, M., Patel, S., & Kim, N. N. (2022). Effects of Flibanserin on Subdomain Scores of the Female Sexual Function Index in Women With Hypoactive Sexual Desire Disorder. Sexual Medicine, 10(6), 100570. https://doi.org/10.1016/j.esxm.2022.100570