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HLD100-E is a specific modified-release formulation of dextroamphetamine sulfate developed by Ironshore Pharmaceuticals for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). It utilizes Ironshore's proprietary DELEXIS drug delivery technology, which is designed to provide a delayed-release and extended-release (DR/ER) profile. This platform consists of a functional film coating that allows for evening dosing with a significant delay in initial drug release, followed by a controlled extended release throughout the following day. This pharmacokinetic profile is intended to target early morning symptoms and maintain therapeutic efficacy throughout the day. HLD100-E was evaluated in Phase II clinical trials (such as NCT02341248) as part of an adaptive trial design to identify the optimal formulation for pediatric and adolescent patients.
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