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ACP SR Sprinkles is an investigational, sustained-release oral formulation of acamprosate developed by Confluence Pharmaceuticals. It is specifically designed for pediatric populations with Fragile X Syndrome and Autism Spectrum Disorders, utilizing a "sprinkle" format that can be mixed with food to accommodate patients with sensory or mechanical swallowing difficulties. Acamprosate is a small molecule that modulates the central nervous system by acting as an NMDA receptor antagonist and a GABA receptor modulator, aiming to correct the imbalance between excitatory and inhibitory signaling characteristic of these neurodevelopmental disorders. The formulation has received Orphan Drug Designation from both the FDA and EMA for the treatment of Fragile X Syndrome.
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