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Fuisz Pharma Releases Clinical Photos of Its Opioid Abuse Detection System
Date:12/6/2010

FDA trend in the abuse deterrence category is to require the disclosure of individual features that relate to deterring abuse.  The consequence of such labeling is that the products that will ultimately dominate this category will be those products that combine multiple deterrence features.   Importantly, other abuse deterrence methods – like the use of antagonists, antagonist sequestration, crush resistant tablet formulations, etc. – do not have clear patent protection and thus are susceptible to generic competition.  In contrast, our highly effective dye methods have dominant, issued patent claims affording them excellent patent protection."

Mr. Fuisz continued, "Because the Fuisz detection features employ inactive, food safe materials, these features can be added to existing drug approvals, including NDAs and ANDAs, as post approval supplements.   This simplified regulatory procedure offers a compelling route to enable companies to add detection features to existing products."

Fuisz Pharma is a private pharmaceutical technology company originated by the Fuiszes. The Fuiszes have made substantial contributions in drug delivery including orally dissolving tablets and novel particle coating systems at Fuisz Technologies; inventing and developing thin film drug delivery technologies at Kosmos Pharma and MonoSol Rx, as well as independently developing extruded sheet technology, and have extensive experience working with big and specialty pharma.  The Fuiszes were recently issued a patent covering the programming of personal analyzers for analyte and clucose levels (US 7,824,612 "Bodily fluid analyzer, and system including same and method for programming same"). Fuisz Pharma has its headquarters in Miami. www.fuisz.com


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