PT-141 (Bremelanotide) Nasal Spray – 10mL

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WOMEN’S SEXUAL HEALTH: An Effect on the Subjective Sexual Response in Premenopausal Women with Sexual Arousal Disorder by Bremelanotide (PT‐141), a Melanocortin Receptor Agonist

Author links open overlay panelLisa E.DiamondPhD*Dennis C.EarleBS*Julia R.HeimanPhD†Raymond C.RosenPhD‡Michael. A.PerelmanPhD§RonaldHarningPhD*

https://doi.org/10.1111/j.1743-6109.2006.00268.xGet rights and content

ABSTRACT

Introduction

 

Melanocortins affect multiple physiological responses, including sexual behaviors. Bremelanotide is a synthetic peptide melanocortin analog of α‐melanocyte‐stimulating hormone that is an agonist at melanocortin receptors MC3R and MC4R.

 

Aim

To evaluate a single intranasal dose of bremelanotide for potential effects on physiological and subjective measurements of sexual arousal and desire in premenopausal women with sexual arousal disorder.

 

Main Outcome Measures

Change in vaginal pulse amplitude during neutral and erotic videos after treatment with bremelanotide or placebo and subjects’ perceptions of physiological and sexual response within 24 hours of treatment with bremelanotide or placebo.

 

Methods

Eighteen premenopausal women with a primary diagnosis of female sexual arousal disorder were randomly assigned to receive a single intranasal dose of 20 mg bremelanotide or matching placebo in a double‐blind manner during the first in‐clinic treatment session, and the alternate medication during the second in‐clinic treatment session. During each session, subjects viewed a 20‐minute neutral video followed by a 20‐minute sexually explicit video. Vaginal photoplethysmography was used to monitor vaginal vasocongestion and questionnaires were used to evaluate perceptions of sexual response within the following 24‐hour period.

 

Results

More women reported moderate or high sexual desire following bremelanotide treatment vs. placebo (P = 0.0114), and a trend toward more positive responses regarding feelings of genital arousal occurred after bremelanotide compared with placebo (P = 0.0833). Among women who attempted sexual intercourse within 24 hours after treatment, significantly more were satisfied with their level of sexual arousal following bremelanotide, compared with placebo (P = 0.0256). Vaginal vasocongestion did not change significantly while viewing erotic videos following bremelanotide administration compared with placebo.

 

Conclusion

This preliminary evaluation suggests the potential for bremelanotide to positively affect desire and arousal in women with female sexual arousal disorder and indicates that bremelanotide is a promising candidate for further evaluation in an at‐home study. Diamond LE, Earle DC, Heiman JR, Rosen RC, Perelman MA, and Harning R. An effect on the subjective sexual response in premenopausal women with sexual arousal disorder by bremelanotide (PT‐141), a melanocortin receptor agonist. J Sex Med 2006;3:628–638.

 

AT-HOME EFFICACY OF AN INTRANASALLY ADMINISTERED MELANOCORTIN RECEPTOR AGONIST, PT141, IN MEN WITH ERECTILE DYSFUNCTION (ED) Hunter Wessells*, Seattle, WA; Harin Padma-Nathan, Beverly Hills, CA; Jacob Rajfer, Torrance, CA; Robert Feldman, Waterbury, CT; Raymond Rosen, Piscataway, NJ; Perry Molinoff, Lisa Diamond, Dennis Earle, Barbara Powers, Cranbury, NJ INTRODUCTION AND OBJECTIVE: Melanocortin receptors in the central nervous system play a role in important behaviors including sexual arousal and body weight regulation. PT -141, a peptide analog of alpha-melanocyte-stimulating hormone, induces erections in normal men and those with ED. We evaluated the safety and efficacy of intranasally (IN) administered PT -14lfor the treatment of male ED in the at-home environment. METHODS: This was a multi-center double-blind, placebo-controlled, parallel group, dose range finding study that enrolled 271 sildenafil-responsive ED patients with an liEF EF domain score of 6-21 (mean = 14.2). After a two-week no-treatment period, patients were randomized to receive an intranasal in-clinic dose to assess exposure levels and tolerability, followed by 10 at-home doses of placebo, 5mg, lOmg, 15mg or 20mg of PT-141 for a four week treatment period. Efficacy was assessed by the change in the liEF Erectile Function (EF) domain score and responses to GAQ and SEP questionnaires. RESULTS: Of the patients who completed at least 3 at home attempts (n = 203), the mean liEF EF score increased in a dose dependent fashion (Figure; p less than 0.05 for 10, 15, and 20 mg) was achieved by 10, 30, 36, 53, and 50% of patients in the placebo, 5, 10, 15, and 20 mg groups respectively. Improved erections (GAQ) were reported by 17, 49, 67, 66, and 66% of patients in the placebo, 5, 10, 15, and 20 mg groups respectively. There were no episodes of syncope or hypotension. The only serious AE reported in this study occurred in one *Presenting author. Vol. 171, No. 4, Supplement, Monday, May 10, 2004 patient who reported a prolonged erection that was painless and required no treatment. Gastrointestinal side-effects were the primary reasons for discontinuation in the higher two higher dose groups. CONCLUSIONS: In this at-home study, PT-141 was shown to be safe and highly effective in inducing high-quality erections in men with ED. IL w IL w ~ =o c: ·- U) Q)c; Cl·- c:«~ «~ E tss c: &’! ::E 10 8 6 4 2 0 Placebo 5mg 10mg 15mg 20mg PT-141 Dose Group

 

 

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WOMEN’S SEXUAL HEALTH: An Effect on the Subjective Sexual Response in Premenopausal Women with Sexual Arousal Disorder by Bremelanotide (PT‐141), a Melanocortin Receptor Agonist

Author links open overlay panelLisa E.DiamondPhD*Dennis C.EarleBS*Julia R.HeimanPhD†Raymond C.RosenPhD‡Michael. A.PerelmanPhD§RonaldHarningPhD*

https://doi.org/10.1111/j.1743-6109.2006.00268.xGet rights and content

ABSTRACT

Introduction

 

Melanocortins affect multiple physiological responses, including sexual behaviors. Bremelanotide is a synthetic peptide melanocortin analog of α‐melanocyte‐stimulating hormone that is an agonist at melanocortin receptors MC3R and MC4R.

 

Aim

To evaluate a single intranasal dose of bremelanotide for potential effects on physiological and subjective measurements of sexual arousal and desire in premenopausal women with sexual arousal disorder.

 

Main Outcome Measures

Change in vaginal pulse amplitude during neutral and erotic videos after treatment with bremelanotide or placebo and subjects’ perceptions of physiological and sexual response within 24 hours of treatment with bremelanotide or placebo.

 

Methods

Eighteen premenopausal women with a primary diagnosis of female sexual arousal disorder were randomly assigned to receive a single intranasal dose of 20 mg bremelanotide or matching placebo in a double‐blind manner during the first in‐clinic treatment session, and the alternate medication during the second in‐clinic treatment session. During each session, subjects viewed a 20‐minute neutral video followed by a 20‐minute sexually explicit video. Vaginal photoplethysmography was used to monitor vaginal vasocongestion and questionnaires were used to evaluate perceptions of sexual response within the following 24‐hour period.

 

Results

More women reported moderate or high sexual desire following bremelanotide treatment vs. placebo (P = 0.0114), and a trend toward more positive responses regarding feelings of genital arousal occurred after bremelanotide compared with placebo (P = 0.0833). Among women who attempted sexual intercourse within 24 hours after treatment, significantly more were satisfied with their level of sexual arousal following bremelanotide, compared with placebo (P = 0.0256). Vaginal vasocongestion did not change significantly while viewing erotic videos following bremelanotide administration compared with placebo.

 

Conclusion

This preliminary evaluation suggests the potential for bremelanotide to positively affect desire and arousal in women with female sexual arousal disorder and indicates that bremelanotide is a promising candidate for further evaluation in an at‐home study. Diamond LE, Earle DC, Heiman JR, Rosen RC, Perelman MA, and Harning R. An effect on the subjective sexual response in premenopausal women with sexual arousal disorder by bremelanotide (PT‐141), a melanocortin receptor agonist. J Sex Med 2006;3:628–638.

 

AT-HOME EFFICACY OF AN INTRANASALLY ADMINISTERED MELANOCORTIN RECEPTOR AGONIST, PT141, IN MEN WITH ERECTILE DYSFUNCTION (ED) Hunter Wessells*, Seattle, WA; Harin Padma-Nathan, Beverly Hills, CA; Jacob Rajfer, Torrance, CA; Robert Feldman, Waterbury, CT; Raymond Rosen, Piscataway, NJ; Perry Molinoff, Lisa Diamond, Dennis Earle, Barbara Powers, Cranbury, NJ INTRODUCTION AND OBJECTIVE: Melanocortin receptors in the central nervous system play a role in important behaviors including sexual arousal and body weight regulation. PT -141, a peptide analog of alpha-melanocyte-stimulating hormone, induces erections in normal men and those with ED. We evaluated the safety and efficacy of intranasally (IN) administered PT -14lfor the treatment of male ED in the at-home environment. METHODS: This was a multi-center double-blind, placebo-controlled, parallel group, dose range finding study that enrolled 271 sildenafil-responsive ED patients with an liEF EF domain score of 6-21 (mean = 14.2). After a two-week no-treatment period, patients were randomized to receive an intranasal in-clinic dose to assess exposure levels and tolerability, followed by 10 at-home doses of placebo, 5mg, lOmg, 15mg or 20mg of PT-141 for a four week treatment period. Efficacy was assessed by the change in the liEF Erectile Function (EF) domain score and responses to GAQ and SEP questionnaires. RESULTS: Of the patients who completed at least 3 at home attempts (n = 203), the mean liEF EF score increased in a dose dependent fashion (Figure; p less than 0.05 for 10, 15, and 20 mg) was achieved by 10, 30, 36, 53, and 50% of patients in the placebo, 5, 10, 15, and 20 mg groups respectively. Improved erections (GAQ) were reported by 17, 49, 67, 66, and 66% of patients in the placebo, 5, 10, 15, and 20 mg groups respectively. There were no episodes of syncope or hypotension. The only serious AE reported in this study occurred in one *Presenting author. Vol. 171, No. 4, Supplement, Monday, May 10, 2004 patient who reported a prolonged erection that was painless and required no treatment. Gastrointestinal side-effects were the primary reasons for discontinuation in the higher two higher dose groups. CONCLUSIONS: In this at-home study, PT-141 was shown to be safe and highly effective in inducing high-quality erections in men with ED. IL w IL w ~ =o c: ·- U) Q)c; Cl·- c:«~ «~ E tss c: &’! ::E 10 8 6 4 2 0 Placebo 5mg 10mg 15mg 20mg PT-141 Dose Group

 

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