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Shire/New River NRP104 submission

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Shire and New River are seeking a pediatric indication for children ages six to 12 for the attention deficit/hyperactivity disorder therapy NRP104. New River submitted an NDA for the amphetamine prodrug Dec. 6, giving FDA an Oct. 6, 2006 standard review action date. Lower abuse liability is one of the key advantages the sponsors hope to claim vis-à-vis currently marketed stimulant ADHD agents. The firms reported positive Phase III data for the new molecular entity in May (Pharmaceutical Approvals Monthly June 2005, In Brief)...

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New River NRP104 Phase III data

New River's d-amphetamine prodrug NRP104 showed statistically significant results for primary and secondary endpoints in a Phase III study of children with attention deficit hyperactivity disorder, the firm reports May 23. The study of 285 patients aged six to 12 showed that each of three doses of NRP104 had a significant outcome for the ADHD Rating Scale (primary) and the Conners Parent Rating Scale (p<0.0001), New River said. New River is collaborating with Shire on NRP104; the firms signed a global commercialization deal in January. NRP104 is expected to reach the market by 2006 (1Pharmaceutical Approvals Monthly February 2005, p. 19)...

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Splitting Colfax into separate fabrication technology and specialty medical technology businesses will help both sides of the business grow, CEO Matthew Trerotola said recently.





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