Robust Growth Predicted for Abuse Deterrent Formulations

FALLS CHURCH, Va., Nov. 18, 2014 /PRNewswire/ -- Spurred by strong public interest, the FDA is actively reviewing guidance on the need for abuse deterrent formulations. The FDA is currently working on a case-by-case basis to determine whether or not opioid based formulations should only receive approval if they possess abuse deterrent properties.  Zohydro™ ER was recently approved without abuse deterrent properties because the formulation has clear medical benefits and therefore, did not initially need abuse deterrent technology. However, there has been backlash regarding this decision and Zogenix (the company responsible for Zohydro) is currently in the process of developing an abuse deterrent formulation of this product.

It is apparent that the Agency is most likely moving in the direction of requiring some form of abuse deterrent technology for newly approved opioid formulations. The current US market for opioid based formulations is almost $4 billion. Technology Catalysts International (TCI) predicts the increased need for abuse deterrent technology will significantly change the dynamics of the market.  Companies will need to determine how to reformulate their products to meet this expanding need, which will also spur the demand for abuse resistant technologies.

TCI, based in Falls Church, Virginia, USA, has been consulting on drug delivery for over 35 years and can assist companies in assessing technologies for reformulation.  Some recent studies on Abuse Deterrent Technologies undertaken by TCI include:

• Abuse deterrent formulations for immediate release and extended release tablets
• Marketed oral formulations in the US, EU, and Japan
• Market trends of abuse deterrent products from 2005-2013 in the US and EU
• Analysis of drug products utilizing abuse deterrent technologies including patent evaluation of abuse deterrent products/technologies
• Abuse deterrent technology for oral thin film products
• FDA guidance regarding abuse deterrence
• Patent infringement analysis for abuse deterrent products
• Market potential for the abuse deterrent market
• Abuse deterrent technology analysis and product assessment
• Perspective of healthcare payers
• Trend analysis of merger and acquisition and out-licensing of products and technologies for abuse deterrence
• Investigations into the mechanisms for abuse deterrence

TCI would be pleased to discuss your specific information requirements.  To discuss potential projects, please contact:

Ajay Rastogi
Vice President
Technology Catalysts International
605 Park Avenue
Falls Church, VA 22046
Email: [email protected] 
Tel: +1 703 531 0257
Website: www.technology-catalysts.com

SOURCE Technology Catalysts International

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