MIAMI, Dec. 6, 2010 /PRNewswire-USNewswire/ -- Fuisz Pharma today released photos of what the clinician will see in a standard nasal otoscopic exam in the case of a patient abusing an opioid, like Oxycontin® and others, through snorting. A food safe dye included in the tablet creates easily visible, long lasting but temporary nasal stain. Crushing and snorting opioids is the most common method of opioid abuse. The photos are taken at 12 hours, 24 hours and 48 hours after snorting. These photos include attempts to defeat the system – which prove futile – by attempting to clean the nose through nasal lavage. The importance of these photos is to demonstrate for the first time an objective criterion for caregivers, emergency personnel and law enforcement personnel to detect opioid abuse. Presently the REMS that are mandated by the FDA do not have any objective criteria wherein the Caregiver and others have the ability to detect abuse. The nasal staining demonstrated by these clinical pictures is not the only detection feature of the Fuisz Closed Loop Diagnostic system. Other methods include the staining the of the oral mucosa where a tablet is crushed and diverted for buccal or sublingual use (instead of the directed swallowing), as well as a method of urine detection that does not require chemistries. These methods are covered by pending patents and issued patent claims (US 7,214,385 "Pharmaceutical Formulation Containing Dye") that are owned by Fuisz Pharma.
Joseph Fuisz, Managing Member for Fuisz Pharma, commented: "The 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
|SOURCE Fuisz Pharma|
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