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news.Shire has presented positive results from a Phase 2, 14-week, flexible dose, multi-center study of Vyvanse (lisdexamfetamine dimesylate) Capsules evaluating its effect in a prospective examination of adults with negative symptom predominant schizophrenia.
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Vyvanse, a prescription medicine used for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD), is administered orally as adjunctive therapy.
Vyvanse was administered to 92 clinically stable patients with predominant negative symptom schizophrenia (ages of 18 to 55), taking established maintenance doses of atypical antipsychotic medications.
Vyvanse demonstrated significant improvement in schizophrenia after 10 weeks, compared to baseline.
The primary efficacy measure was the modified SANS-18 score, which is the sum of all non-global SANS item ratings of affective flattening, inappropriate affect, alogia, avolition-apathy, and anhedonia-asociality.
The safety profile present in this 4-week double-blind phase was similar to that seen in the prior 10-week period, and was similar across placebo and Vyvanse groups.
Schizophrenia Research Program director Henry Nasrallah said if the results were confirmed in controlled clinical trials, they would represent a significant step forward to address the unmet need of treating the negative symptoms of schizophrenia.
Shire Research and Development Program SVP Jeffrey Jonas said the company is well-positioned to provide scientific leadership to review and develop pathways for this understanding with global clinical communities and regulatory authorities.