Navigation Links
Fuisz Pharma Releases Clinical Photos of Its Opioid Abuse Detection System

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.

SOURCE Fuisz Pharma
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Fuisz Announces Issuance of Patent for the New Generation of Glucose and Other Analyte Analyzers
2. Fuisz Pharma Announces Acquisition of Key Anti Opiate Abuse Patent to Complement its Anti Opiate Abuse Platform
3. FUISZ Announces Advances in Devices and Solid Dosage Form
4. Fuisz Pharma Announces Novel Anti Abuse System for Opiates
5. Fuisz Tobacco Announces Clinical Study Results for Fuisz Tobacco Sheet Strip; Super Enhanced Bioavailability of Nicotine From Its Tobacco Sheet Strip Supports Efficacy of Low Dose Tobacco Product
6. Caraco Receives Sun Pharma Proposal to Purchase All Outstanding Shares
7. Purdue Pharma L.P. Re-launches Partners Against Pain Website
8. Pharmacyclics Reports CLL Results from Preclinical and Clinical Studies of its Btk Inhibitor PCI-32765
9. Portola Pharmaceuticals Announces Data Presentations Highlighting Syk/JAK Inhibitor Clinical Development Program at 52nd American Society of Hematology Annual Meeting
10. Neuraltus Pharmaceuticals Reports Clinical Results from Phase 1/2 NP002 Study in the Treatment of Dyskinesias Resulting from Levodopa Therapy for Parkinsons Disease
11. Access Pharmaceuticals Updates MuGard Website With First Patient Testimonial Video
Post Your Comments:
(Date:11/26/2015)... Nov. 26, 2015 Research and Markets ( ... "Advanced Wound Care Market by Type (Dressings, Therapy Devices, ... (In-Patient Facility, Out-Patient Facility), and Geography - Global Forecast ... --> --> The purpose ... and forecast of the global advanced wound care market. ...
(Date:11/26/2015)... India , November 26, 2015 ... --> adds ... Report" and "Investigation Report on China ... and 2021 forecasts data and information ... . ...
(Date:11/26/2015)... , Nov. 26, 2015 Research ... addition of the "2016 Future Horizons and ... (TDM) Market: Supplier Shares, Country Segment Forecasts, Competitive ... --> --> ... analysis of the Italian therapeutic drug monitoring market, ...
Breaking Medicine Technology:
(Date:11/26/2015)... ... November 26, 2015 , ... Health-E-minds ... collaborated with Women’s Web – an online resource for Indian women looking ... and emotional well-being relationship, life balance, stress, professional development, and lifestyle. Health-E-minds ...
(Date:11/25/2015)... ... 25, 2015 , ... The holiday season is jam-packed with ... palates of attendees is of the utmost importance. Whether you are cooking at ... these recipes a try this holiday season. , Turkey Croquettes , ...
(Date:11/25/2015)... ... November 25, 2015 , ... Dr. John Pierce, Medical Director at the Ageless ... treatment with the Capillus272™ Pro laser therapy cap. FDA cleared for safety and efficacy, ... without the need for surgery, prescription pills, or topical foams. , “Capillus272™ Pro ...
(Date:11/25/2015)... ... 25, 2015 , ... According to an article published November 10th ... widely heralded as a breakthrough for performing hernia repairs. The article explains that the ... is that it can greatly reduce the pain that a patient might otherwise experience ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... athletic programs, launches new Wimbledon Athletics Facebook page to educate the ... for unsuspected cardiac abnormalities. About 2,000 people under the age of 25 die ...
Breaking Medicine News(10 mins):