PMID- 37584285
OWN - NLM
STAT- MEDLINE
DCOM- 20231117
LR  - 20231117
IS  - 1098-108X (Electronic)
IS  - 0276-3478 (Linking)
VI  - 56
IP  - 11
DP  - 2023 Nov
TI  - Efficacy, safety, and tolerability of nivasorexant in adults with binge-eating 
      disorder: A randomized, Phase II proof of concept trial.
PG  - 2120-2130
LID - 10.1002/eat.24039 [doi]
AB  - OBJECTIVE: This Phase II, placebo-controlled, double-blind study investigated the 
      efficacy, safety, and tolerability of nivasorexant in the treatment of adults 
      with moderate to severe binge-eating disorder (BED). METHODS: Adults meeting the 
      DSM-5 BED criteria were randomized 1:1 to placebo or nivasorexant (100 mg 
      b.i.d.). The primary endpoint was the change from baseline to Week 12 in the 
      number of binge eating (BE) days per week. Exploratory efficacy endpoints 
      included cessation of BE in the last 4 weeks of treatment; and change from 
      baseline to Week 12 in the number of BE episodes/week, the clinician global 
      impression (CGI) of change, the Yale-Brown Obsessive-Compulsive Scale modified 
      for BE, and the Hamilton rating scale for depression (HAMD-17). Key safety 
      outcomes included treatment-emergent adverse events (TEAEs) and adverse events of 
      special interest (i.e., somnolence and fatigue). RESULTS: Sixty-eight 
      participants were randomized to each treatment arm. The change from baseline to 
      Week 12 in the number of BE days/week was the same for placebo (least squares 
      mean [LSM]: -2.93) and nivasorexant (LSM: -2.93), with no difference between the 
      treatment groups (LSM difference = .000 [95% confidence interval (CI): -.69, 
      .69], p = .9992). Furthermore, no differences between treatment groups were 
      observed in the exploratory efficacy endpoints. Nivasorexant was well tolerated; 
      the overall incidence of TEAEs was balanced between treatment groups, and the 
      frequency of somnolence and fatigue in the nivasorexant group were similar to 
      placebo. DISCUSSION: In this proof-of-concept study, 100 mg b.i.d. nivasorexant 
      did not improve BE in adults with moderate to severe BED. PUBLIC SIGNIFICANCE: 
      The results of this Phase II study indicate that nivasorexant was well tolerated 
      in adults with BED, but did not improve binge eating behavior over placebo. 
      Further research is needed to improve our understanding of the role of the 
      orexin-1 receptor in BED.
CI  - (c) 2023 Wiley Periodicals LLC.
FAU - McElroy, Susan L
AU  - McElroy SL
AUID- ORCID: 0000-0002-8879-0865
AD  - Lindner Center of HOPE, Department of Psychiatry & Behavioral Neuroscience, 
      University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.
FAU - Coloma, Preciosa M
AU  - Coloma PM
AD  - Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.
FAU - Berger, Benjamin
AU  - Berger B
AD  - Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.
FAU - Guerdjikova, Anna I
AU  - Guerdjikova AI
AUID- ORCID: 0000-0002-8141-0698
AD  - Lindner Center of HOPE, Department of Psychiatry & Behavioral Neuroscience, 
      University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.
FAU - Joyce, J Mark
AU  - Joyce JM
AD  - Clinical Neuroscience Solutions, Inc., Jacksonville, Florida, USA.
FAU - Liebowitz, Michael R
AU  - Liebowitz MR
AD  - Medical Research Network, New York, New York, USA.
AD  - Department of Psychiatry, Columbia University, New York, New York, USA.
FAU - Pain, Scott
AU  - Pain S
AD  - Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.
FAU - Rabasa, Cristina
AU  - Rabasa C
AD  - Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.
LA  - eng
GR  - Idorsia Pharmaceuticals Ltd/
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20230816
PL  - United States
TA  - Int J Eat Disord
JT  - The International journal of eating disorders
JID - 8111226
RN  - SJT761GEGS (Lisdexamfetamine Dimesylate)
SB  - IM
MH  - Humans
MH  - Adult
MH  - *Binge-Eating Disorder/drug therapy/chemically induced
MH  - Lisdexamfetamine Dimesylate/therapeutic use
MH  - Sleepiness
MH  - *Bulimia
MH  - Double-Blind Method
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Phase 2
OT  - binge-eating disorder
OT  - clinical trial
OT  - orexin-1 receptor
OT  - proof-of-concept
EDAT- 2023/08/16 12:43
MHDA- 2023/11/17 15:23
CRDT- 2023/08/16 06:34
PHST- 2023/07/25 00:00 [revised]
PHST- 2023/05/14 00:00 [received]
PHST- 2023/07/25 00:00 [accepted]
PHST- 2023/11/17 15:23 [medline]
PHST- 2023/08/16 12:43 [pubmed]
PHST- 2023/08/16 06:34 [entrez]
AID - 10.1002/eat.24039 [doi]
PST - ppublish
SO  - Int J Eat Disord. 2023 Nov;56(11):2120-2130. doi: 10.1002/eat.24039. Epub 2023 
      Aug 16.