This site is intended for US health care professionals only.

IMPORTANT SAFETY INFORMATION

This site is intended for US healthcare professionals only.

WARNING: ABUSE AND DEPENDENCE

  • CNS stimulants (amphetamines and methylphenidate-containing products), including Vyvanse, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.
Full Safety Information Below

Vyvanse is indicated for the treatment of moderate to severe binge eating disorder (B.E.D.) in adults. Vyvanse is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of Vyvanse for the treatment of obesity have not been established.

Efficacy of Vyvanse® (lisdexamfetamine dimesylate) was Evaluated in 2 Identically Designed Phase 3 Studies in Adults with Moderate to Severe B.E.D.1

STUDY DESIGN


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’s 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).*

  • 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 using criteria from Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision.


PRIMARY ENDPOINT:

  • Change from baseline at Week 12 in the mean number of binge days per week compared with placebo

KEY SECONDARY ENDPOINTS1:

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

Dosing in Phase 3 Studies1

ALL VYVANSE® (lisdexamfetamine dimesylate) SUBJECTS STARTED AT 30 MG/DAY AND WERE TITRATED TO AN OPTIMAL DOSE OF 50 OR 70 MG/DAY†1


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

STUDY 1: Vyvanse® (lisdexamfetamine dimesylate) Significantly Reduced Mean Binge Days per Week1

REDUCTION IN LS MEAN BINGE DAYS PER WEEK FROM BASELINE AT WEEK 121

SAFETY INFORMATION

  • Contraindications
    Patients should not take Vyvanse if they are:
    • hypersensitive to amphetamines or other ingredients of Vyvanse. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have occurred.
    • taking monoamine oxidase inhibitors (MAOI) or have taken an MAOI within the past 14 days. Hypertensive crisis can occur.

PRIMARY ENDPOINT

STUDY 2: Vyvanse® (lisdexamfetamine dimesylate) Significantly Reduced Mean Binge Days per Week1

REDUCTION IN LS MEAN BINGE DAYS PER WEEK FROM BASELINE AT WEEK 121

Assessment of Key Secondary Endpoints

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 behaviors2,3

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 thoughts

  • 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 behaviors

  • 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.

Vyvanse® (lisdexamfetamine dimesylate) Reduced Obsessive Thoughts and Compulsive Behaviors Related to Binge Eating, Using Y-BOCS-BE

SIGNIFICANTLY GREATER REDUCTION (IMPROVEMENT) IN LS MEAN Y-BOCS-BE TOTAL SCORE FOR VYVANSE VS PLACEBO FROM BASELINE AT WEEK 122,3

SAFETY INFORMATION

  • Warnings and Precautions
    • Prior to and during treatment assess for the presence of cardiac disease. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Note that sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulants at recommended doses, as well as sudden death in children and adolescents with structural cardiac abnormalities and other serious heart problems while taking CNS stimulants at recommended doses. Evaluate patients with exertional chest pain, unexplained syncope, or arrhythmias while taking Vyvanse.

Vyvanse demonstrated overall improvement using CGI-I

  • 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*2
  • 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*2

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

  • 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*2
  • 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*2

*P<.001 vs placebo

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S38425  04/18

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