AwesomeCapital: Novel Sunovion Therapy for Binge-Eating Cuts Weight in Obese Adults

Sunday, October 6, 2019

Novel Sunovion Therapy for Binge-Eating Cuts Weight in Obese Adults

Dasotraline, a novel binge eating disorder treatment, helped reduce body weight in a secondary analysis, a researcher reported here.
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, according to Leslie Citrome, MD, of New York Medical College in Valhalla.
Study participants on dasotraline also saw a 2-point reduction in BMI versus a 0.2 increase among those on placebo, she reported at Psych Congress 2019.
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)

The efficacy outcomes were previously reported in two phase II/III randomized studies, which found dasotraline significantly reduced the number of binge days per week in people with moderate-to-severe binge eating disorder compared with placebo. After 12 weeks of treatment, dasotraline treatment was associated with a average 3.74-day reduction in the number of binge-eating days per week versus a 2.75-day reduction seen in placebo (P<0.0001).
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.
All participants (ages 18-55) were diagnosed with at least moderate binge-eating disorder according to DSM-5 criteria. This 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. 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.
In 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 behaviors.
Measured on the Yale-Brown Obsessive-Compulsive scale Modified for Binge Eating (YBOCS-BE), dasotraline participants had a significant change in total score (effect size=0.96), obsessions subscale score (effect 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,” Citrome’s group reported.
In July 2019, Sunovion announced the FDA accepted 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 studies were funded by Sunovion Pharmaceuticals. Co-authors are company employees.
Citrome disclosed multiple relevant relationships with industry including Sunovion.