FDA Publishes Guidance on Opioid Analgesic Drugs

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The draft guidance describes a benefit-risk assessment framework for evaluating applications for opioid analgesic drugs.

On June 20, 2019, FDA published draft guidance describing the application of the benefit-risk assessment framework used in evaluating applications for opioid analgesic drugs. The guidance offers a summary of the information that can be supplied with these applications to assist FDA in making the assessment.

The draft guidance is part of the agency’s plan to combat the opioid crisis and was developed based on recommendations from a study from the National Academies of Science, Engineering, and Medicine about the approaches the agency can take to improve its benefit-risk framework for opioids.

“In terms of patient safety, the agency recommends that companies consider providing information on whether their drug has any characteristics that would mitigate the risks of overdose, abuse or the development of addiction. Companies should also indicate whether their drugs have novel or greater risks compared to other opioids on the market and also note the public health implications of their products in terms of risks to non-patients, including members of the patient’s household, visiting relatives, friends and others,” FDA stated in a press release.


The agency will be holding a public meeting on Sept. 17, 2019 to discuss the benefit-risk assessment for opioid analgesics. It will include discussion on approval requirements and preapproval incentives.

Source: FDA