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ARTICLE | Clinical News

Vyvanse lisdexamfetamine dimesylate: Development discontinued

February 10, 2014 8:00 AM UTC

Shire discontinued development of Vyvanse to treat MDD after top-line data from the identical, double-blind, international Phase III SPD489-322 and SPD489-323 trials showed that once-daily oral Vyvanse as adjunctive treatment missed the primary endpoint in both trials of reducing mean MADRS total score from baseline at week 8 to week 16 vs. placebo (6.1 vs. 6.3 points, p=0.883 for SPD489-322; 7.3 vs. 6.8 points, p=0.583 for SPD489-323). SPD489-322 enrolled 404 patients and SPD489-323 enrolled 426 patients. The trials enrolled patients aged 18-65 with MDD who inadequately responded to antidepressant monotherapy with a selective serotonin reuptake inhibitor (SSRI) or a serotonin/norepinephrine reuptake inhibitor (SNRI).

The trials consisted of an 8-week, single-blind lead-in phase with an SSRI or SNRI and an 8-week, double-blind adjunctive treatment phase. Patients who demonstrated an inadequate response to the antidepressant treatment at week 8, defined as an MADRS total score of >=18 points and a <50% reduction in MADRS total score from the lead-in baseline at week 0, entered the adjunctive treatment phase and were randomized to receive Vyvanse or placebo. During the double-blind period, Vyvanse dosing was optimized over the range of 20-70 mg based on clinical criteria. ...