Vyvanse: Phase III data
Top-line data from the double-blind, randomized-withdrawal portion of the international Phase III Study SPD489-346 in 275 patients with moderate to severe binge eating disorder showed that once-daily oral Vyvanse for 26 weeks met the primary endpoint of improving time to relapse of binge eating symptoms vs. placebo (p<0.001). Additionally, a significantly smaller proportion of patients receiving Vyvanse relapsed vs. placebo (3.7% vs. 32.1%). A relapse was defined as a >=2-point increase in the investigator’s assessment of CGI-S score from baseline of the randomization-withdrawal portion and >=2 binge eating days per week for 2 consecutive weeks.
The trial consisted of a 4-week screening period; a 12-week, open-label treatment period (4 weeks of dose optimization and 8 weeks of maintenance treatment); and a 26-week, double-blind randomized-withdrawal period. During the dose-optimization period, all Vyvanse-treated patients started dosing at 30 mg and then titrated in 20 mg increments to either 50 or 70 mg. Responders in the open-label treatment period, defined as patients who achieved <=1 binge day each week for 4 consecutive weeks prior to the last visit of the open-label treatment period and had a CGI-S score of <=2 points at the same visit, were randomized to receive the same optimized dose of Vyvanse or placebo in the randomized-withdrawal period. ...