B.E.D. STUDIES

CLINICAL DATA FOR MODERATE TO SEVERE BINGE EATING DISORDER (B.E.D.) IN ADULTS

Hypothetical patient portrayal. Individual results may vary.

Moderate to severe B.E.D. in adults efficacy & safety data

SELECT A STUDY


STUDIES343 & 344

TWO IDENTICALLY DESIGNED STUDIES

How reduction in binge days was evaluated in 2 identically designed studies

Both studies were 12-week, randomized, double-blind, parallel-group, placebo-controlled, dose-optimization studies of adults aged 18 to 55 years (N=374 and N=350) with protocol-defined moderate to severe B.E.D.1

Moderate to severe B.E.D. was defined in the studies as a subject having at least 3 binge days per week for 2 weeks prior to the baseline visit and a Clinical Global Impression–Severity (CGI-S) score ≥4 (at least moderately ill).*1

  • A "binge day" was defined as a day with at least 1 binge episode, using the subject’s daily binge diary
  • Baseline was defined as the weekly average of the number of binge days per week for the 14 days immediately prior to the baseline visit (visit 0)

*Diagnosis was confirmed based on criteria from the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision, as these studies were conducted before the release of the DSM-5®.

Primary Endpoint: Change from baseline at week 12 in the mean number of binge days per week compared with placebo.1,2

Key Secondary Endpoints1,2:

  • Change from baseline in total score on the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE)
  • Global impression of B.E.D. improvement as measured on the Clinical Global Impression–Improvement (CGI-I) scale
  • Proportion of subjects with 4-week cessation from binge eating behavior (free from binge episodes in the last 28 days of the studies)

Assessment of Key Secondary Endpoints

Y-BOCS-BE

Study clinicians used the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) to assess the change over time in obsession with binge eating thoughts and compulsiveness of binge eating behaviors.2

Y-BOCS-BE is a composite score composed of 10 criteria, each rated from 0 (“no symptoms”) to 4 (“extreme symptoms”), and summed to a total score ranging from 0 to 40.2,3

Obsession with binge eating thoughts3:

  • Time occupied by obsessive thoughts to binge eat
  • Interference due to thoughts to binge eat
  • Distress associated with thoughts to binge eat
  • Resistance of thoughts to binge eat
  • Degree of control over obsessive thoughts to binge eat

Compulsiveness of binge eating behaviors3:

  • Time spent on compulsive behaviors to binge eat
  • Interference due to binge eating
  • Distress associated with binge eating
  • Resistance to binge eating
  • Degree of control over binge eating

Clinical Global Impression-Improvement (CGI-I)2

At each study visit, clinicians used the CGI-I scale to assess overall improvement in the clinical state of the patient relative to the patient’s baseline. CGI-I responses were dichotomized into 2 categories: Improved (included very much improved and much improved) and Not Improved (included minimally improved, no change, minimally worse, much worse, and very much worse).

4-week cessation of binge eating episodes2,4

4-week cessation of binge eating was defined as no binge episodes during the 28 days leading up to the final study visit. If a subject discontinued prior to having 28 days’ diary information or had missing diary information in the last 28 days, they were counted as not having experienced a 4-week cessation.

Dosing

All Vyvanse subjects started at 30 mg/day and were titrated to an optimal dose of 50 or 70 mg/day. Patients were not treated with 30 mg/day beyond week 1.†1,2

Subjects were titrated from 30 mg/day to 50 mg/day. Additional increases to 70 mg/day were made as tolerated and clinically indicated. The maximum dose was 70 mg/day.

Primary Endpoint: Vyvanse significantly reduced mean binge days per week1

STUDY 1:
Reduction in LS mean binge days per week from baseline to week 121,2,5

STUDY 2:
Reduction in LS mean binge days per week from baseline at week 121,2,5

Key Secondary Endpoints: Vyvanse reduced obsessive thoughts and compulsive behaviors related to binge eating as measured by Y-BOCS-BE1,2

Significantly greater reduction (improvement) in LS mean Y-BOCS-BE total score for Vyvanse vs placebo from baseline at week 122,4

Vyvanse demonstrated overall improvement using CGI-I2

Study 1 results—at week 12, 82.1% of adult patients taking Vyvanse were considered improved and 17.9% not improved vs 47.3% and 52.7%, respectively, for placebo

Study 2 results—at week 12, 86.2% of adult patients taking Vyvanse were considered improved and 13.8% not improved vs 42.9% and 57.1%, respectively, for placebo

P<.001 vs placebo.

Vyvanse patients were more likely to experience 4-week cessation of binge eating episodes2

Study 1 results—40% of adult patients treated with Vyvanse experienced a 4-week cessation of binge eating, vs 14.1% of adult patients treated with placebo§

Study 2 results—36.2% of adult patients treated with Vyvanse experienced a 4-week cessation of binge eating, vs 13.1% of adult patients treated with placebo§

§P<.001 vs placebo.

STUDY346

MAINTENANCE OF EFFICACY STUDY

How maintenance of efficacy was evaluated

This 38-week study (N=418) was preceded by a 4-week screening phase; followed by a 12-week open-label treatment phase (4 weeks of dose-optimization with 8 weeks of dose-maintenance); a 26-week double-blind, placebo-controlled, randomized-withdrawal phase (n=267); and a follow-up visit one week after treatment completion.1,2

Primary Endpoint: Maintenance of efficacy as measured by time to relapse in the double-blind, placebo-controlled, randomized-withdrawal phase1,2

  • Relapse was defined as ≥2 binge days per week for 2 consecutive weeks prior to any visit and an increase in CGI-S score of ≥2 points from randomized-withdrawal baseline1,2
  • A “binge day” was defined as a day with at least 1 binge-eating episode, using the subject’s binge diary1

Adults aged 18-55 years were eligible to participate in the study if they met DSM-IV-TR® criteria for B.E.D. and were considered moderate to severe (≥3 binge eating days per week during the 14 days before open-label baseline) and had a CGI-S score ≥4 (at least moderately ill) at screening and open-label baseline.1,2

At the end of the open-label treatment phase, subjects were considered Vyvanse responders if they presented with ≤1 binge eating days per week for 4 consecutive weeks prior to the last visit at the end of the open-label treatment phase and a CGI-S score ≤2 at the same visit. Vyvanse responders were randomized to continuation of Vyvanse or placebo for up to 26 weeks for observation for relapse.1,2

CGI-S=Clinical Global Impressions-Severity

Dosing

All subjects were started on Vyvanse 30 mg/day and dose-optimized to either 50 mg/day or 70 mg/day as tolerated and clinically indicated.2

*Based on dose-optimization during open-label treatment phase

Vyvanse was superior to placebo based on time to relapse in adult patients with moderate to severe B.E.D.1,2

Proportion of patients who relapsed based on Kaplan-Meier estimate*1-3

After 6 months, Vyvanse patients were ~10 times less likely to relapse vs placebo (hazard ratio 0.090, 95% CI [0.04,0.23]; P<0.001).2

*Relapse was defined as ≥2 binge days per week for 2 consecutive weeks prior to any visit and an increase in CGI-S score of ≥2 points from randomized-withdrawal baseline.1,2

Periodically reevaluate patients for the continued need for Vyvanse.


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References
  1. Vyvanse [package insert]. Lexington, MA: Shire US Inc.
  2. McElroy SL, Hudson J, Ferreira-Cornwell MC, et al. Lisdexamfetamine dimesylate for adults with moderate to severe binge eating disorder: results of two pivotal phase 3 randomized controlled trials. Neuropsychopharmacology. 2016;41(5):1251-1260.
  3. Data on file; SPD489-152; Shire US Inc.
  4. Data on file; SPD489-169; Shire US Inc.
  5. Data on file; SPD489-155; Shire US Inc. 
References
  1. Vyvanse [package insert]. Lexington, MA: Shire US Inc.
  2. Hudson JI, McElroy SL, Ferreira-Cornwell MC, Radewonuk J, Gasior M. Efficacy of lisdexamfetamine in adults with moderate to severe binge-eating disorder: a randomized clinical trial. JAMA Psychiatry. 2017;74(9):903–910.
  3. Data on file; SPD489-212; Shire US Inc. 

INDICATION AND IMPORTANT SAFETY INFORMATION