Shire plc (SHPGY) Reports Vyvanse Met Primary Endpoint in Phase II for MDD Treatment
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Shire plc (Nasdaq: SHPGY), announced positive Phase II results in a prospective clinical study of Vyvanse (lisdexamfetamine dimesylate) Capsules, (CII) as adjunctive therapy to primary antidepressant treatment in adults with partial or full remission of recurrent major depressive disorder (MDD) and significant, persistent cognitive impairments. Lisdexamfetamine dimesylate is a prescription medicine currently approved in the US, Canada, and Brazil for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). Vyvanse should only be used to treat ADHD.
Shire is investigating the use of Vyvanse as adjunctive therapy for patients with MDD. Some patients with MDD may continue to have cognitive impairment despite resolution of depressive symptoms following antidepressant therapy, although the time course and prevalence of cognitive symptoms in patients with MDD has not been fully characterized. This study, which examined MDD patients with partially or fully remitted symptoms of depression, met its primary end point, which was, change from baseline to end point in the Global Executive Composite (GEC) T-score of the Behavioral Rating Inventory of Executive Function - Adult Version (BRIEF-A) self-report. The BRIEF-A (self-report) is a 75-item instrument that assesses behaviors associated with specific domains of executive functions in adults. This scale is used in a variety of conditions in addition to depression.
This exploratory, double-blind, placebo-controlled, parallel-group, multi-center study consisted of a two-week screening period, a nine-week double-blind period and a two-week single-blind period. During the entire study, subjects continued taking established maintenance doses of antidepressant monotherapy. Subjects in this study had mild or less than mild depressive symptoms (total score of d 18 on the Montgomery-Åsberg Depression Rating Scale [MADRS] at screening and baseline). The screening was followed by 1:1 randomization to Vyvanse (n = 71) or placebo (n = 72) augmentation for 9 weeks. Double-blind Vyvanse (or placebo) was administered orally as adjunctive therapy (20 to 70 mg per day, titrated over the initial 6 weeks), with the optimal individual dose being continued during a 3-week dose maintenance period. A 2-week single-blind phase followed the double-blind phase wherein all subjects were administered placebo.
Shire is investigating the use of Vyvanse as adjunctive therapy for patients with MDD. Some patients with MDD may continue to have cognitive impairment despite resolution of depressive symptoms following antidepressant therapy, although the time course and prevalence of cognitive symptoms in patients with MDD has not been fully characterized. This study, which examined MDD patients with partially or fully remitted symptoms of depression, met its primary end point, which was, change from baseline to end point in the Global Executive Composite (GEC) T-score of the Behavioral Rating Inventory of Executive Function - Adult Version (BRIEF-A) self-report. The BRIEF-A (self-report) is a 75-item instrument that assesses behaviors associated with specific domains of executive functions in adults. This scale is used in a variety of conditions in addition to depression.
This exploratory, double-blind, placebo-controlled, parallel-group, multi-center study consisted of a two-week screening period, a nine-week double-blind period and a two-week single-blind period. During the entire study, subjects continued taking established maintenance doses of antidepressant monotherapy. Subjects in this study had mild or less than mild depressive symptoms (total score of d 18 on the Montgomery-Åsberg Depression Rating Scale [MADRS] at screening and baseline). The screening was followed by 1:1 randomization to Vyvanse (n = 71) or placebo (n = 72) augmentation for 9 weeks. Double-blind Vyvanse (or placebo) was administered orally as adjunctive therapy (20 to 70 mg per day, titrated over the initial 6 weeks), with the optimal individual dose being continued during a 3-week dose maintenance period. A 2-week single-blind phase followed the double-blind phase wherein all subjects were administered placebo.
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