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Clinical Trials Network: Special FDA Designation Validates Need for Autism Clinical Trials

April 17, 2008

Neuropharm Group plc, sponsor of the Study of Fluoxetine in Autism (SOFIA) clinical trial, received "Fast Track" designation by the US Food and Drug Administration (FDA) last week, thereby affirming the urgent

need for medicines that target autism. According to the FDA website (www.fda.gov), "Fast Track is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions." Fast Track designations are granted only in specific circumstances when a drug targets a serious unmet medical need. This designation for a new drug application for autism is an important recognition that autism is a high-priority on the global health care agenda.

SOFIA is the first industry-sponsored trial for Autism Speaks' Clinical Trials Network (CTN), and will include over 120 children and adolescents with autism enrolled across the U.S. at participating CTN sites. The study is evaluating the efficacy of Neuropharm's new melt-in-the-mouth formulation for the treatment of repetitive behaviors in autism. This study will be a crucial part of an application to receive an autism indication for this formulation of fluoxetine.

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Neuropharm is a specialty pharmaceutical company focused on the development of medicines for the treatment and management of neurodevelopmental disorders.

Read Neuropharm's full press release here

Visit the CTN webpage to learn more about the SOFIA study.