FDA issues guidance on benefit-risk assessments for opioids

The US Food and Drug Administration (FDA) has issued a new draft guidance on its assessment of the benefit-risk of opioid pain medications amid the addiction crisis in the USA.

Information that can be supplied by opioid analgesic drug applicants to assist the agency – including on the broader public health effects of these products in the context of this crisis – is included in the guidance, entitled Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework.

"Companies should also indicate whether their drugs have novel or greater risks compared to other opioids on the market"The agency is also withdrawing 2014 draft guidance, Analgesic Indications: Developing Drug and Biological Products. Following discussions with industry and other stakeholders, the FDA wants to provide more targeted information in critical areas of development using a series of new draft guidances to speed development.