FLIBANSERIN (ADDYI®)



















  • For the satisfying sexual events outcome, patients were asked the following questions: "Did you have a sexual event?" and "Was the sex satisfying for you?"
  • Average age of study participants was 36 years
  • Dropout rate was 31% for flibanserin and 22% for placebo
  • Reference [2]
Number of satisfying sexual events over past 28 days (24 week study)
STUDY 1 Flibanserin 100 mg at bedtime
(n=280)
Placebo
(n=290)
Baseline 3 2.7
Change from baseline 1.6 0.8
Treatment difference
(95% CI)
0.9
(0.3 to 1.4)
STUDY 2 Flibanserin 100 mg at bedtime
(n=365)
Placebo
(n=372)
Baseline 2.6 2.7
Change from baseline 1.8 1.1
Treatment difference
(95% CI)
0.6
(0.1 to 1.2)
STUDY 3 Flibanserin 100 mg at bedtime
(n=532)
Placebo
(n=536)
Baseline 2.5 2.7
Change from baseline 2.5 1.5
Treatment difference
(95% CI)
1.0
(0.4 to 1.5)

  • In studies 1 and 2, a daily electronic diary was used to record each subject's sexual desire. Patients rated their daily desire on a scale from 0 (no desire) to 3 (strong desire).
  • *In study 3, sexual desire was recorded every 4 weeks. Patients were asked 2 questions: 1. “Over the past 4 weeks, how often did you feel sexual desire or interest?”, with responses ranging from 1 (almost never or never) to 5 (almost always or always); 2. “Over the past 4 weeks, how would you rate your level (degree) of sexual desire or interest?”, with responses ranging from 1 (very low or none at all) to 5 (very high)
  • Average age of study participants was 36 years
  • Dropout rate was 31% for flibanserin and 22% for placebo
  • Reference [2]
Sexual desire outcomes (24 week study)
STUDY 1 Flibanserin 100mg at bedtime
(n=280)
Placebo
(n=290)
Baseline 12.9 11.8
Change from baseline 9.1 6.9
Treatment difference
(95% CI)
2.2
(-0.1 to 4.6)
STUDY 2 Flibanserin 100mg at bedtime
(n=365)
Placebo
(n=372)
Baseline 12.1 10.2
Change from baseline 8.3 6.7
Treatment difference
(95% CI)
0.8
(-0.3 to 4.0)
STUDY 3 Flibanserin 100mg at bedtime
(n=532)
Placebo
(n=536)
Baseline 1.9* 1.9*
Change from baseline 1.0* 0.7*
Treatment difference
(95% CI)
0.3*
(0.2 to 0.4)





  • Reference [2]
Side effect Flibanserin
(N=1556)
Placebo
(N=1543)
Dizziness 11.4% 2.2%
Somnolence 11.2% 2.9%
Nausea 10.4% 3.9%
Fatigue 9.2% 5.5%
Insomnia 4.9% 2.8%
Dry mouth 2.4% 1.0%