Challenges and Opportunities in the Development of Abuse Deterrent Transdermal Opioid Therapies

Treatment of chronic pain with opioids is currently a therapeutic
necessity, but it often causes problems with addiction
and drug abuse. Moreover, opioid abuse presents a
large burden to society on a global scale. In the United
States, the Food and Drug Administration encourages
development programs to bring abuse deterrent (AD)
opioid medications to the market, and many of these
programs have been executed via the 505(b)(2) regulatory
pathway. Therefore, in recent years a number of products
have successfuly achieved AD labeling status in the USA;
however, none of those products have been transdermal
drug delivery systems (TDDS). This discussion reviews
current literature and offers perspectives on the challenges
and opportunities in development of an AD TDDS.
Technical and regulatory opportunities for the design of
an AD TDDS are extensive, given that there is currently
no FDA-approved TDDS product with an abuse deterrent
claim. However, the challenges that attend the final
design of a successful AD transdermal end product are
also extensive. The patch product must maintain wearability,
shelf life stability, and therapeutic drug delivery
over the shelf life. Otherwise, the patch must be able to
demonstrate the necessary AD characteristics that lead to
a successful label claim for specified routes of abuse.

Author(s): Joshua A. Eldridge

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