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B.E.D. STUDIES

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

Clinical Data for Moderate to Severe 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

Two Identically Designed Studies Maintenance of Efficacy Study
Adverse Reactions
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

Dosing for Vyvanse®. After 4 weeks of dosing optimization, there was an 8-week dose-maintenance period.

†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 343:
Reduction in LS mean binge days per week from baseline to week 121,2,5

Study 343 for Vyvanse®: Reduction in LS mean binge days per week baseline to week 12.

STUDY 344:
Reduction in LS mean binge days per week from baseline at week 121,2,5

Study 344 for Vyvanse®: Reduction in LS mean binge days per week from baseline at week 12.

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
YBOCS-BE graph of Vyvanse® at baseline compared to placebo baseline.

Vyvanse demonstrated overall improvement using CGI-I2

Study 343 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 344 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 343 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 344 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

Vyvanse® dosing: Week 1 through 12- week open-label treatment phase. Week 12 through 38 randomized withdrawal phase.

*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

Proportion of patients on Vyvanse® who relapsed based on Kaplan-Meier estimate.

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: Takeda Pharmaceuticals U.S.A., 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: Takeda Pharmaceuticals U.S.A., 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. 
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