This article is more than 5 years old. Information may no longer be current.
FDA approves Vyvanse labeling update to include new binge-eating disorder data
Click Here to Manage Email Alerts
The FDA recently approved a supplemental New Drug Application to update the U.S. labeling of Vyvanse to include new long-term maintenance data in adults with moderate or severe binge eating disorder, according to a press release from the manufacturer.
“The FDA approval for the labeling update to include maintenance of efficacy data from the first-ever longer-term pharmacologic study in adults with moderate-to-severe [binge-eating disorder] advances our understanding of the efficacy and safety profile of Vyvanse for adults living with the disorder,” Philip J. Vickers, PhD, global head of research and development at Shire, said in a press release. “Collectively, the data and labeling update represent Shire’s commitment to supporting patients and the health care community by expanding the growing body of research on [binge-eating disorder] with longer-term data in this disorder.”
The labeling will now include maintenance findings from a phase 3, 38-week, multicenter, double-blind, placebo-controlled, randomized withdrawal study among 267 adults aged 18 to 55 years with moderate-to-severe binge-eating disorder.
During the 4-week dose-optimization period, study participants received 30 mg of Vyvanse (lisdexamfetamine dimesylate, Shire) per day and then titrated weekly in 20 mg increments to an optimal dose, either 50 mg or 70 mg per day. Participants who met response criteria (ie, one or fewer binge days each week for 4 consecutive weeks and Clinical Global Impressions-Severity scores of 2 or lower) at the end of the 12-week open-label phase were randomly assigned to lisdexamfetamine dimesylate or placebo.
During the 26-week randomized withdrawal phase, participants continued receiving an optimal dose of lisdexamfetamine dimesylate (n = 136) or switched to placebo (n = 131).
During the open-label phase (n = 411), three participants experienced serious adverse events and 22 participants discontinued the study due to treatment-emergent adverse events.
The most common treatment-emergent adverse events were dry mouth, headache, insomnia, decreased appetite, nausea, anxiety, constipation, hyperhidrosis, feeling jittery, and diarrhea.
During the randomized-withdrawal phase, two participants experienced serious adverse events and six patients on lisdexamfetamine dimesylate reported treatment-emergent adverse events that led to study discontinuation. The most common treatment-emergent adverse events included nasopharyngitis, headache, upper respiratory tract infection, and dry mouth.
“These data help health care professionals make more informed decisions when discussing treatment options for [binge-eating disorder] in adults,” Susan L. McElroy, MD, of the University of Cincinnati College of Medicine, said in the release. “Further, the updated Vyvanse labeling with this longer-term maintenance of efficacy data will offer health care professionals a better understanding of how the medication may be incorporated into broader treatment plans for adults with moderate-to-severe [binge-eating disorder].”