Robust Growth Predicted for Abuse Deterrent Formulations
May 1, 2015
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.
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