Phase 3 findings indicated lisdexamfetamine dimesylate reduced risk for relapse in moderate to severe binge-eating disorder over 6 months.
“Lisdexamfetamine dimesylate is approved for adults with moderate-to-severe binge-eating disorder in the United States and Canada,” James I. Hudson, MD, ScD, of McLean Hospital and Harvard Medical School, and colleagues wrote. “In two identically designed, randomized, double-blind, placebo-controlled trials, dose-optimized lisdexamfetamine dimesylate, 50 mg/d or 70 mg/d, produced clinically meaningful and statistically significant reductions in binge-eating days per week vs. placebo in adults with protocol-defined moderate-to-severe [binge-eating disorder].”
To determine lisdexamfetamine dimesylate efficacy for moderate to severe binge-eating disorder in adults, researchers conducted a phase 3, double-blind, placebo-controlled, randomized withdrawal study among 418 individuals at 49 clinical research study sites. Study participants met DSM-IV-R criteria for moderate-to-severe binge-eating disorder. During an open-label phase, participants were randomly assigned to receive 50 mg or 70 mg of lisdexamfetamine dimesylate for 12 weeks. Responders were then randomly assigned to continue lisdexamfetamine dimesylate (n = 137) or receive placebo (n= 138) for a 26-week, double-blind, randomized withdrawal phase. Safety analysis included 411 participants.
Overall, 3.7% of responders who received lisdexamfetamine dimesylate met criteria for relapse, compared with 32.1% of responders who received placebo.
Results from a log-rank test indicated superiority of lisdexamfetamine dimesylate vs. placebo for time to relapse, with a hazard ratio of 0.09 (95% CI, 0.04-0.23).
“Following initial response to open-label lisdexamfetamine, time to relapse to binge eating over 6 months was greater in those continuing lisdexamfetamine treatment than in those randomized to placebo. The estimated hazard for relapse with lisdexamfetamine was also lower than with placebo. The safety and tolerability profile was consistent with lisdexamfetamine studies in adults with moderate-to-severe [binge-eating disorder]and with its profile in ADHD.” – by Amanda Oldt
Disclosure: Hudson reports receiving consulting fees and grant support from Shire Development LLC, diaMentis, Genentech, Pronutria Biosciences, F. Hoffmann-LaRoche Ltd, and Sunovion Pharmaceuticals; and grant support from Genentech and Sunovion Pharmaceuticals. Please see the study for a full list of relevant financial disclosures.