Sexual Health

Sexual dysfunction often affects one’s self-confidence and relationship with partner. Fortunately, this condition is very treatable with bremelanotide. In fact, the FDA approved bremelanotide in June 2019 as a therapeutic option for women with low libido after it showed an increase in sexual desire and reduction in distress in two replicate phase 3 trials involving women with hypoactive sexual desire disorder (HSDD). [1-2] It now joins flibanserin, the only other drug approved by the FDA for the treatment of HSDD in premenopausal women.
Numerous human studies have also shown promising results with regards to the therapeutic benefits of bremelanotide on sexual health:
1. In premenopausal women with sexual dysfunctions, bremelanotide self-administration at various does (0.75, 1.25 or 1.75 mg) as desired over 12 weeks, resulted in significant improvements in female sexual function index total score and female sexual distress scale-desire/arousal/orgasm total score compared to placebo. [3]
2. In female subjects with arousal disorder, administration of 20-mg bremelanotide given as an intranasal spray on “as required” basis 45–60 minutes before attempting sexual intercourse, was associated with significantly greater intercourse satisfaction compared to placebo. [4]
3. In premenopausal women with sexual arousal disorder, administration of a single intranasal dose of 20 mg bremelanotide was associated with moderate or high sexual desire and improved satisfaction with their level of sexual arousal compared to placebo treatment. [5]
4. In clinical trials, administration of bremelanotide in healthy women showed increased vaginal blood flow as well as increased sexual desire and arousal. [6-8]
5. Administration of bremelanotide to normal men and to patients with erectile dysfunction (ED) resulted in a rapid dose-dependent increase in erectile activity. [9]
6. In healthy male subjects and in patients with an inadequate response to Viagra, bremelanotide administration at doses greater than 1 mg resulted in a statistically significant erectile response. [10-11]
7. In a first Phase IIB at home study, administration of bremelanotide resulted in significant improvements in erectile function as assessed by the International Index of Erectile Function (IIEF). [12]
8. Co-administration of sildenafil and 7.5 mg intranasal bremelanotide has been shown to induce significantly prolonged time of penile erections compared with sildenafil alone. [13]
9. In a 12 week phase IIb trial recruiting 726 non-diabetic men suffering from ED, bremelanotide administration at a dose of 5 mg was associated with significantly higher scores in the International Index of Erectile Function (IIEF-5) Questionnaire. [14]

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