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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

entration. MDD affects approximately five million patients in the United States alone and total costs for treating this condition exceeded $83.1 billion in 2002. It is estimated that MDD will become the second leading cause of morbidity worldwide across all ages by 2020.

While an extensive number of anti-depressants have been approved for monotherapy in MDD, many patients remain symptomatic and disabled by incomplete resolution of MDD symptoms despite treatment with anti-depressant monotherapy at appropriate doses and trial duration. These patients with an inadequate therapeutic response represent up to two-thirds of patients treated with anti-depressant monotherapy. Commonly, these inadequate responders remain symptomatic with respect to mood, concentration, motivation, and interest, often reflected by disability in multiple life domains (e.g., work/school, social life, and home/family life). Major health authorities recognize inadequate response in MDD as a valid target for pharmacologic intervention, with two medications being current approved in the US and/or the EU.

About Vyvanse(R)

Vyvanse is a prescription medicine for the treatment of 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.

IMPORTANT SAFETY INFORMATION

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.

- Vyvanse should not be taken by patients who have:

Heart disease or hardening of the arteries, moderate to severe high blood pressure, overactive thyroid gland (hyperthyroidism), gl
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SOURCE Shire plc
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