Meeting News

Bremelanotide improves sexual desire in women

NASHVILLE, Tenn. — The investigational drug bremelanotide enhanced sexual function in women regardless of the contraceptive used and its duration of use, according to data from two different abstracts presented at the American College of Obstetricians and Gynecologists Annual Clinical and Scientific Meeting.

Bremelanotide is a synthetic peptide analogue of the -melanocyte–stimulating hormone, according to previously published information.

Anita H. Clayton, MD, of the University of Virginia School of Medicine and James A. Simon, MD, of George Washington University, led reviews of three separate phase 3 trials of the same cohort: a double-blind, randomized study that provided approximately 1,200 premenopausal women with a 1.75 mg subcutaneous dose of bremelanotide or placebo for 24 weeks. An autoinjector pen with the drug was provided for use “on demand.”

Group of Happy Women 
The investigational drug bremelanotide enhanced sexual function in women regardless of the contraceptive used and its duration of use, according to data from two different abstracts presented at the American College of Obstetricians and Gynecologists Annual Clinical and Scientific Meeting.
Source:Adobe

They found from baseline:

  • Mean change in a Female Sexual Function Index -Desire-domain (desire score) was 0.35 (P < .0001);
  • Mean change in the part of a Female Sexual Distress Scale-Desire-Arousal/Orgasm Item 13 (distress score) was -0.33 (P < .0001);
  • Mean differences in a desire domain score was 0.42 for 6 to 18 months of Hypoactive Sexual Desire Disorder duration, 0.41 for 18 to 33 months, 0.28 for 33 to 60 months and 0.33 for 60 to 360 months;
  • Mean differences in the part of a distress score evaluated were -0.46 for 6 to 18 months of Hypoactive Sexual Desire Disorder duration, -0.43 for 18 to 33 months, -0.14 for 33 to 60 months and -0.29 for 60 to 360 months;
  • Numerical differences in desire domain score in those who received hormonal contraceptives and bremelanotide concurrently vs. those who received placebo (P = .1557);
  • Statistically significant increases vs. those receiving placebo but not using hormonal contraceptives concurrently with bremelanotide (P < .001); and statistically significant changes on the part of the orgasm distress scale that was scored in those receiving bremelanotide (P = .047)

Bremelanotide has a PDUFA date of June 23, 2019, according to a press release from Amag Pharmaceuticals, the drug’s manufacturer. – by Janel Miller

References:

Amag Pharmaceuticals. “Amag Pharmaceuticals presents new data on bremelanotide and hypoactive sexual desire disorder at the ISSWSH/ISSM joint meeting.” http://www.amagpharma.com/news/amag-pharmaceuticals-presents-new-data-on-bremelanotide-and-hypoactive-sexual-desire-disorder-at-the-isswshissm-joint-meeting/. Accessed April 23, 2019.

Clayton AH, et al. Clin Ther. 2017;doi:10.1016/j.clinthera.2017.01.018.

Clayton AH, et al. “Bremelanotide for hypoactive sexual desire disorder: Contraceptive subgroups efficacy analysis.”

Simon JA, et al. “Efficacy of bremelanotide across hypoactive sexual desire disorder duration subgroups.”

Abstracts presented at: American College of Obstetricians and Gynecologists Annual Clinical and Scientific Meeting; May 3-6, 2019; Nashville.

Disclosures: Both Clayton and Simon report many relevant financial disclosures. Please see the abstracts for specifics.

Editor's Note: This story has been updated from a previous version to better reflect the benefits that have been studied in bremelanotide.

NASHVILLE, Tenn. — The investigational drug bremelanotide enhanced sexual function in women regardless of the contraceptive used and its duration of use, according to data from two different abstracts presented at the American College of Obstetricians and Gynecologists Annual Clinical and Scientific Meeting.

Bremelanotide is a synthetic peptide analogue of the -melanocyte–stimulating hormone, according to previously published information.

Anita H. Clayton, MD, of the University of Virginia School of Medicine and James A. Simon, MD, of George Washington University, led reviews of three separate phase 3 trials of the same cohort: a double-blind, randomized study that provided approximately 1,200 premenopausal women with a 1.75 mg subcutaneous dose of bremelanotide or placebo for 24 weeks. An autoinjector pen with the drug was provided for use “on demand.”

Group of Happy Women 
The investigational drug bremelanotide enhanced sexual function in women regardless of the contraceptive used and its duration of use, according to data from two different abstracts presented at the American College of Obstetricians and Gynecologists Annual Clinical and Scientific Meeting.
Source:Adobe

They found from baseline:

  • Mean change in a Female Sexual Function Index -Desire-domain (desire score) was 0.35 (P < .0001);
  • Mean change in the part of a Female Sexual Distress Scale-Desire-Arousal/Orgasm Item 13 (distress score) was -0.33 (P < .0001);
  • Mean differences in a desire domain score was 0.42 for 6 to 18 months of Hypoactive Sexual Desire Disorder duration, 0.41 for 18 to 33 months, 0.28 for 33 to 60 months and 0.33 for 60 to 360 months;
  • Mean differences in the part of a distress score evaluated were -0.46 for 6 to 18 months of Hypoactive Sexual Desire Disorder duration, -0.43 for 18 to 33 months, -0.14 for 33 to 60 months and -0.29 for 60 to 360 months;
  • Numerical differences in desire domain score in those who received hormonal contraceptives and bremelanotide concurrently vs. those who received placebo (P = .1557);
  • Statistically significant increases vs. those receiving placebo but not using hormonal contraceptives concurrently with bremelanotide (P < .001); and statistically significant changes on the part of the orgasm distress scale that was scored in those receiving bremelanotide (P = .047)

Bremelanotide has a PDUFA date of June 23, 2019, according to a press release from Amag Pharmaceuticals, the drug’s manufacturer. – by Janel Miller

References:

Amag Pharmaceuticals. “Amag Pharmaceuticals presents new data on bremelanotide and hypoactive sexual desire disorder at the ISSWSH/ISSM joint meeting.” http://www.amagpharma.com/news/amag-pharmaceuticals-presents-new-data-on-bremelanotide-and-hypoactive-sexual-desire-disorder-at-the-isswshissm-joint-meeting/. Accessed April 23, 2019.

Clayton AH, et al. Clin Ther. 2017;doi:10.1016/j.clinthera.2017.01.018.

Clayton AH, et al. “Bremelanotide for hypoactive sexual desire disorder: Contraceptive subgroups efficacy analysis.”

Simon JA, et al. “Efficacy of bremelanotide across hypoactive sexual desire disorder duration subgroups.”

Abstracts presented at: American College of Obstetricians and Gynecologists Annual Clinical and Scientific Meeting; May 3-6, 2019; Nashville.

Disclosures: Both Clayton and Simon report many relevant financial disclosures. Please see the abstracts for specifics.

Editor's Note: This story has been updated from a previous version to better reflect the benefits that have been studied in bremelanotide.

    See more from American College of Obstetrics and Gynecology Annual Clinical and Scientific Meeting