Dasotraline significantly reduces binge eating related obsessive compulsive behaviour: Study

Treatment with a norepinephrine-dopamine reuptake inhibitor (NDRI), dasotraline in patients with binge eating disorder (BED) helped to reduce body weight, according to study results presented at the Psych Congress 2019. The findings were presented by Leslie Citrome, New York Medical College in Valhalla.

Another secondary analysis led by Citrome presented another secondary analysis at Psych Congress 2019, showing that dasotraline significantly reduced binge-related obsessional thoughts and compulsive behaviours.

Mayo Clinic defines binge-eating disorder as a serious eating disorder in which a person frequently consumes unusually large amounts of food and feel unable to stop eating.

In July 2019, Sunovion announced the FDA acceptance of their New Drug Application for dasotraline seeking the indication for moderate-to-severe binge eating disorder, with an action date of May 14, 2020.

The study included 155 participants randomized to receive a flexible, once-daily dose of 4, 6, or 8 mg of dasotraline. They were compared with 160 individuals on placebo. The average daily dose of dasotraline was 5.5 mg/day.

DSM-5 criteria was defined as at least two or more binge-eating days per week for a minimum of 6 months, or 3-plus binge-eating days per week during the past 2 weeks before randomization.

All participants (ages 18-55) were diagnosed with at least moderate binge-eating disorder according to DSM-5 criteria. The vast majority of the participants were white females, with an average of 4.3 binge-eating days per week and 5.6 binge-eating episodes per week.

Over 75% of the cohort had obesity at the start of the study, evenly distributed between obesity class I (24.9% BMI 30 to <35), II (29.3% BMI 35 to <40), and III (21.8% BMI ≥40). Around 18% of the cohort were considered overweight, with a BMI from 25 to <30, but <6% of the cohort had a BMI <25.

Key findings of the study include:

• After 12 weeks, the once-daily investigational long-acting dopamine/norepinephrine reuptake inhibitor was associated with a significant 12.57 lbs (5.7 kg) reduction in body weight reduction compared with a 0.88 lb (0.4 kg) gain in placebo.


• Study participants on dasotraline also saw a 2-point reduction in BMI versus a 0.2 increase among those on placebo.


• Far more participants on dasotraline achieved a "clinically meaningful" reduction in weight (≥5%) than those on placebo did (45.3% vs 4.1%).


• Nearly 14% of patients on dasotraline were also able to achieve a weight reduction of ≥10%, while no patients on placebo were able to.


• When broken down by weight class, those who began dasotraline with obesity (classes 1-3) saw the greatest magnitude of weight reduction over the course of 12 weeks:
  
  
  
  • Obesity: -13.67 lbs (-6.2 kg)
  
  
  • Overweight: -12.79 lbs (-5.8 kg)
  
  
  • Normal weight: -10.14 lbs (-4.6 kg)
  
  
  
  

Another secondary analysis led by Citrome showed that:

• Measured on the Yale-Brown Obsessive-Compulsive scale Modified for Binge Eating (YBOCS-BE), dasotraline participants had a significant change in total score (effect data-size=0.96), obsessions subscale score (effect data-size=0.95), and compulsions subscale score (effect size =0.87) compared with placebo. Improvements in all these scales were significant after only 2 weeks of treatment.


• Compared with placebo, significant improvements were seen in several types of obsessional thoughts and compulsive behaviors measured for in the questionnaire subscales:
  
  
  
  • Degree of control over thoughts to binge eat
  
  
  • Resistance to thoughts to binge eat
  
  
  • Distress associated with thoughts to binge eat
  
  
  • Interference due to thoughts to binge eat
  
  
  • Time occupied by obsessive thoughts to binge eat
  
  
  
  


• Patients on dasotraline also saw a significant improvement in symptoms, as rated by the Binge Eating Clinical Global Impression-Severity (CGI-S) score.


• Among these patients an endpoint CGI-Severity score of 1 (normal) was achieved by 52.3% of patients and was associated with a mean endpoint YBOCS-BE score of 0.5, indicating remission of binge-related obsessions and compulsions in the majority of patients.

Taken together, these secondary analyses of dasotraline found the medication to be associated with meaningful reductions in binge eating days per week, weight, and BED-related compulsions and obsessions after 12 weeks of treatment.

Citrome L, et al "Effect of dasotraline on body weight in patients with binge-eating disorders" Psych Congress 2019; Poster 143.