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news.Shire Pharmaceuticals has announced plans to seek approval for four new drug candidates that have shown promise in clinical testing. The areas targeted by the treatments include the central nervous system and the gastrointestinal region.
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Data from both phase II and phase III clinical trials evaluated the following four compounds: MTS, SPD503 and NRP104, all for the treatment of ADHD, and SPD476 for ulcerative colitis.
MTS (methylphenidate transdermal system) is a methylphenidate-containing transdermal patch being developed in conjunction with Noven Pharmaceuticals. During both phase II and III clinical trials researchers achieved significant improvement in performance and behavior compared to placebo, with a safety profile consistent with that reported for approved oral methylphenidate products.
The study of SPD503, guanfacine hydrochloride in extended-release tablets, met its primary endpoints in safety and efficacy. SPD503 is a non-stimulant, nonscheduled product with a differentiated mechanism of action for treating ADHD.
NRP104, a novel prodrug of d-amphetamine with reduced abuse potential being developed in collaboration with New River Pharmaceuticals, also showed statistically significant improvement for patients.
Shire’s first global gastrointestinal product opportunity, SPD476, yielded favorable results in patients with acute, mild to moderate ulcerative colitis compared to those on placebo. SPD476 is a novel hydrophilic matrix formulation of 5-ASA (aminosalicylate).