A 12-month, open-label trial of flibanserin in North American women with generalized acquired hypoactive sexual desire disorder (HSDD): the sunflower trial

Abstract

OBJECTIVE: To assess long-term safety/tolerability and maintenance efficacy of flibanserin treatment for HSDD in premenopausal women.DESIGN: Prospective, 12-month, multicenter, flexible-dose, open-label study.MATERIALS AND METHODS: Premenopausal women with primary generalized acquired HSDD who completed the North American trials of flibanserin were eligible for inclusion. Flibanserin was initiated at 50 mg qhs and adjusted (by response/tolerability) to 25 mg bid, 50 mg qhs, 50 mg bid, or 100 mg qhs. Primary endpoint was frequency of adverse events (AEs). Secondary endpoints included Female Sexual Distress Scale-Revised (FSDS-R) and Female Sexual Function Index (FSFI). Remitter categorization at baseline was used to differentiate FSFI remitters (FSFI score >26.55, indicating no clinical sexual dysfunction) from FSFI non-remitters [FSFI score ≤ 26.55]. No formal statistical tests were used.RESULTS: 1,723 women (mean age 37.5 years) received flibanserin and 962 (55.8%) completed 12 months' treatment. The number of women exposed to flibanserin 25 mg bid, 50 mg qhs, 50 mg bid, or 100 mg qhs for ≥180 days was 9, 162, 53, and 883, respectively. 723 (42.0%) patients experienced ≥1 treatment-related AE (somnolence 15.3%; fatigue 5.9%; dizziness 5.7%; nausea 4.2%; sedation 1.6%); 185 (10.7%) discontinued due to AEs. No deaths or treatment-related serious AEs were noted. At study end, 42% of baseline non-remitters had improved their FSFI score to remission level. The proportion of baseline FSFI remitters in remission rose from 83% at week 4 to a stable value of about 90%. A large decrease was seen in FSDS-R score at study end.CONCLUSION: Long-term flibanserin treatment was well tolerated, with no new or unexpected safety findings. Sexual function improved in women who were not FSFI remitters at baseline, and was maintained in those who were remitters at baseline. The total number of remitters was higher at study end. OBJECTIVE: To assess long-term safety/tolerability and maintenance efficacy of flibanserin treatment for HSDD in premenopausal women. DESIGN: Prospective, 12-month, multicenter, flexible-dose, open-label study. MATERIALS AND METHODS: Premenopausal women with primary generalized acquired HSDD who completed the North American trials of flibanserin were eligible for inclusion. Flibanserin was initiated at 50 mg qhs and adjusted (by response/tolerability) to 25 mg bid, 50 mg qhs, 50 mg bid, or 100 mg qhs. Primary endpoint was frequency of adverse events (AEs). Secondary endpoints included Female Sexual Distress Scale-Revised (FSDS-R) and Female Sexual Function Index (FSFI). Remitter categorization at baseline was used to differentiate FSFI remitters (FSFI score >26.55, indicating no clinical sexual dysfunction) from FSFI non-remitters [FSFI score ≤ 26.55]. No formal statistical tests were used. RESULTS: 1,723 women (mean age 37.5 years) received flibanserin and 962 (55.8%) completed 12 months' treatment. The number of women exposed to flibanserin 25 mg bid, 50 mg qhs, 50 mg bid, or 100 mg qhs for ≥180 days was 9, 162, 53, and 883, respectively. 723 (42.0%) patients experienced ≥1 treatment-related AE (somnolence 15.3%; fatigue 5.9%; dizziness 5.7%; nausea 4.2%; sedation 1.6%); 185 (10.7%) discontinued due to AEs. No deaths or treatment-related serious AEs were noted. At study end, 42% of baseline non-remitters had improved their FSFI score to remission level. The proportion of baseline FSFI remitters in remission rose from 83% at week 4 to a stable value of about 90%. A large decrease was seen in FSDS-R score at study end. CONCLUSION: Long-term flibanserin treatment was well tolerated, with no new or unexpected safety findings. Sexual function improved in women who were not FSFI remitters at baseline, and was maintained in those who were remitters at baseline. The total number of remitters was higher at study end.