PMID- 35147466
OWN - NLM
STAT- MEDLINE
DCOM- 20220315
LR  - 20220531
IS  - 1931-843X (Electronic)
IS  - 1540-9996 (Linking)
VI  - 31
IP  - 2
DP  - 2022 Feb
TI  - Safety Profile of Bremelanotide Across the Clinical Development Program.
PG  - 171-182
LID - 10.1089/jwh.2021.0191 [doi]
AB  - Background: Bremelanotide, a melanocortin receptor agonist, is Food and Drug 
      Administration (FDA)-approved for the treatment of premenopausal women with 
      acquired, generalized hypoactive sexual desire disorder. Methods: Review of 
      bremelanotide's safety profile from the clinical development program (phases 1 
      through 3). Results: The clinical development program comprised 3500 subjects in 
      43 completed studies. In the phase 3 studies, subjects took bremelanotide for up 
      to 18 months. The most common adverse events (AEs) were nausea (40.0% vs. 1.3%), 
      flushing (20.3% vs. 1.3%), headache (11.3% vs. 1.9%), and injection site 
      reactions (5.4 vs. 0.5), bremelanotide versus placebo groups, respectively, in 
      the integrated double-blind portion of the phase 3 studies (N = 1247). Nausea was 
      the most common reason for bremelanotide discontinuation. There were no deaths; a 
      few subjects experienced serious AEs. Focal hyperpigmentation was rare when 
      bremelanotide was dosed in accordance with label recommendations, but it occurred 
      in more than one-third of subjects following up to 16 consecutive daily dosings. 
      Small and transient but statistically significant blood pressure increases were 
      observed during ambulatory blood pressure monitoring. Most drug-drug interactions 
      were not clinically significant, except for interactions that lowered plasma 
      concentrations of indomethacin and naltrexone. In the double-blind portion of the 
      integrated phase 3 studies, 70% of the bremelanotide group proceeded to the 
      open-label phase of the studies versus 87% of those on placebo. Conclusions: The 
      AEs associated with bremelanotide are mostly mild to moderate. Although not 
      deemed clinically important, bremelanotide should be used with caution in 
      patients at risk of cardiovascular disease, and blood pressure should be well 
      controlled during treatment. Clinical Trial Registration number: NCT02333071 
      [Study 301] and NCT02338960 [Study 302].
FAU - Clayton, Anita H
AU  - Clayton AH
AUID- ORCID: 0000-0003-4372-0879
AD  - Department of Psychiatry and Neurobehavioral Sciences, University of Virginia, 
      Charlottesville, Virginia, USA.
FAU - Kingsberg, Sheryl A
AU  - Kingsberg SA
AD  - Department of Reproductive Biology and Department of Psychiatry, University 
      Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.
FAU - Portman, David
AU  - Portman D
AD  - Sermonix Pharmaceuticals, Columbus, Ohio, USA.
FAU - Sadiq, Amama
AU  - Sadiq A
AD  - AMAG Pharmaceuticals, Inc., Waltham, Massachusetts, USA.
FAU - Krop, Julie
AU  - Krop J
AD  - AMAG Pharmaceuticals, Inc., Waltham, Massachusetts, USA.
FAU - Jordan, Robert
AU  - Jordan R
AD  - Palatin Technologies, Inc., Cranbury, New Jersey, USA.
FAU - Lucas, Johna
AU  - Lucas J
AD  - Palatin Technologies, Inc., Cranbury, New Jersey, USA.
FAU - Simon, James A
AU  - Simon JA
AD  - George Washington University and IntimMedicine Specialists, Washington, District 
      of Columbia, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02333071
SI  - ClinicalTrials.gov/NCT02338960
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Womens Health (Larchmt)
JT  - Journal of women's health (2002)
JID - 101159262
RN  - 0 (Peptides, Cyclic)
RN  - 581-05-5 (alpha-MSH)
RN  - 6Y24O4F92S (bremelanotide)
SB  - IM
MH  - *Blood Pressure Monitoring, Ambulatory
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - *Libido
MH  - Peptides, Cyclic/adverse effects
MH  - alpha-MSH/adverse effects
OTO - NOTNLM
OT  - bremelanotide
OT  - hypoactive sexual desire disorder
OT  - premenopausal
EDAT- 2022/02/12 06:00
MHDA- 2022/03/16 06:00
CRDT- 2022/02/11 12:11
PHST- 2022/02/11 12:11 [entrez]
PHST- 2022/02/12 06:00 [pubmed]
PHST- 2022/03/16 06:00 [medline]
AID - 10.1089/jwh.2021.0191 [doi]
PST - ppublish
SO  - J Womens Health (Larchmt). 2022 Feb;31(2):171-182. doi: 10.1089/jwh.2021.0191.