Abuse-Deterrent Opioids: FDA Regulatory Options Aired At Meeting
This article was originally published in The Pink Sheet Daily
Executive Summary
Brand industry favors two- to three-year period for withdrawal or reformulation of products without abuse-deterrent features, while generic industry calls for expedited review pathway. Purdue and Zogenix agree to waive three-year market exclusivity for their respective hydrocodone products.
You may also be interested in...
Campaign Against Woodcock’s US FDA Commissioner Bid Has Begun
Opioid issues delayed Robert Califf’s confirmation as FDA commissioner. Could they prevent the nomination of Janet Woodcock?
Sharfstein On Zohydro: FDA Should Require Opioid Abuse Deterrent Standards
Former FDA Principal Deputy Commissioner Joshua Sharfstein suggests FDA create a pathway for development of new products for simultaneous treatment of chronic pain and opioid disorder.
Abuse Reduction Claim In Opioid Label Will Be Difficult To Attain
FDA draft guidance says there is no clear epidemiologic strategy for gathering the data to demonstrate that has reduced abuse; the agency outlines four possible kinds of abuse deterrence claims, three of which can be obtained through pre-market studies.