Global biopharmaceutical company Shire reports positive results from a signal-finding study of Vyvanse (lisdexamfetamine dimesylate) Capsules (CII) assessing the drug’s effect in a prospective examination of adults with negative symptom predominant schizophrenia. This study met its pre-defined primary end points.
This investigational, phase II, 14-week, flexible dose, multi-center study consisted of a 10 week open-label (n = 92) and a 4 week double-blind component (n = 69). Vyvanse was administered orally as adjunctive therapy (20 to 70 mg per day, titrated over 7 weeks) to 92 clinically stable patients with predominant negative symptom schizophrenia (ages of 18 to 55), taking established maintenance doses of atypical antipsychotic medications. In the open-label, primary efficacy analysis, Vyvanse demonstrated significant improvement (p
Vyvanse is a prescription medicine currently approved for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). Efficacy for Vyvanse in ADHD was based on two controlled trials in children aged 6 to 12, one controlled trial in adolescents aged 13 to 17, and two controlled trials in adults. Vyvanse should be used as part of a total treatment program that may include counseling or other therapies.