12th Jun 2014 13:31
LONDON (Alliance News) - Shire PLC said Thursday that it had agreed to a written request from the US Food and Drug Administration to conduct studies into the potential use of Vyvanse for the treatment of attention deficit hyperactivity disorder, or ADHD, in children aged 4 to 5.
It expects to begin the first trial in the first half of 2015.
Shire is currently developing design protocols for three clinical trials with Vyvanse: a study to determine appropriate dosing safety and tolerability, an efficacy and safety study, and a long-term safety study.
It will also establish a Data Monitoring Committee to monitor patient safety throughout.
"Shire is committed to continuing to add to the scientific body of knowledge about ADHD treatment options for patients,? said Philip Vickers Head of Research and Development.
Shares in Shire were trading down 0.3% at 3,582.00 Thursday afternoon.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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