The U.S. Food and Drug Administration (FDA) issued a draft guidance document to assist industry in developing new formulations of opioid drugs with abuse-deterrent properties.
The document “Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling,” explains the FDA’s current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties, how those studies will be evaluated by the agency, and what labeling claims may be approved based on the results of those studies.
FDA is seeking public comment on the draft guidance for 60 days and encourages additional scientific and clinical research that will advance the development and assessment of abuse-deterrent technologies. Instructions on how to submit comments will be announced in an upcoming Federal Register notice. The FDA will also hold a public meeting to discuss and receive feedback on the draft guidance. In finalizing the guidance document, the agency will consider the information received from the public.
The FDA: Draft Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling is available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf
Source: Federal Drug Administration – January 9, 2013