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Shire Reports Positive Signal Finding Study of Investigative Use of Vyvanse(R) (lisdexamfetamine dimesylate) Capsules as Adjunctive Treatment in Major Depressive Disorder
Date:10/29/2010

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PHILADELPHIA, October 29, 2010 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced results from a Phase 2 signal finding study of Vyvanse(R) [lisdexamfetamine dimesylate (or SPD489)] in patients who have had residual symptoms of depression following treatment with LEXAPRO(R) (escitlopram) for Major Depressive Disorder (MDD). Based on these findings, Shire intends to advance discussions with regulators to explore the development of program parameters for additional studies of Vyvanse as adjunctive therapy to primary anti-depressant treatments in patients with MDD.

Vyvanse is a prescription medicine currently approved in the US for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Efficacy was based on two controlled trials in children aged six to 12 and two controlled trials in adults. Vyvanse should be used as part of a total treatment program that may include counseling or other therapies.

Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Vyvanse in a safe place to prevent misuse and abuse. Selling or giving away Vyvanse may harm others, and is against the law. Vyvanse is a stimulant medication. Misuse of stimulants may cause sudden death and serious cardiovascular adverse events.

In this investigational 14-week, double-blind, randomized, placebo-controlled study (n=246), Vyvanse was administered orally as an adjunctive therapy for 6 weeks to adults between the ages of 18 and 55, who continued to experience symptoms of depression following a prospective 8-week treatment period with 20 mg/day of escitalopram/LEXAPRO(R). Continuing symptoms were defined as a total HAM-D17 score greater than or equal to 4 at the end of this prospective phase (n=177). In the randomized period, e
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