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ARTICLE | Clinical News

Shire's Vyvanse meets in Phase III binge eating trials

November 6, 2013 1:50 AM UTC

Shire plc (LSE:SHP; NASDAQ:SHPG) said once-daily oral Vyvanse lisdexamfetamine dimesylate met the primary endpoint in the identical Phase III Study SPD489-343 and SPD489-344 to treat binge eating disorder. Vyvanse reduced the number of binge eating days per week from baseline to weeks 11-12 vs. placebo (p<0.001 for both trials). The double-blind, international trials enrolled 773 patients aged 18-55 with moderate to severe binge eating disorder. By 3Q14, Shire plans to submit an sNDA to FDA for Vyvanse to treat binge eating disorder. ...