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.

Vyvanse® Demonstrated Significant Maintenance of Efficacy as Measured by Time to Relapse1

STUDY DESIGN1,2


  • 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

PRIMARY ENDPOINT1


  • The primary endpoint was maintenance of efficacy as measured by time to relapse in the double-blind, placebo-controlled, randomized-withdrawal phase
  • 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

STUDY SUBJECTS


  • 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 baseline1,2
  • 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 relapse1

CGI-S=Clinical Global Impressions-Severity
A “binge day” was defined as a day with at least one binge episode, using the subject’s binge diary.

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 indicated2,3


  • 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 baseline1,2
  • 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 relapse1

CGI-S=Clinical Global Impressions-Severity
A “binge day” was defined as a day with at least one binge episode, using the subject’s binge diary.

Vyvanse Was Superior To Placebo Based on Time to Relapse in Adult Patients With Moderate to Severe B.E.D.1

PRIMARY ENDPOINT RESULT: For patients who continued on Vyvanse, significant maintenance of efficacy was demonstrated vs. placebo based on time to relapse (P<0.001)1,2

PROPORTION OF PATIENTS WHO RELAPSED BASED ON KAPLAN-MEIER ESTIMATE1,3

After 6 months, Vyvanse patients were ~10 times less likely to relapse vs. placebo (hazard ratio 0.090, 95% CI [0.036,0.229]; P<0.001).3

Periodically re-evaluate patients for the continued need for Vyvanse.

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S38425  04/18

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