FDA Ponders New Approach for Opioid Risk-Benefit Assessments

June 27, 2019

Sponsors of opioid drugs would have to study whether their candidates are better than currently approved drugs under new guidelines the FDA is considering.

In a new draft guidance, the FDA calls for sponsors to answer questions about the broader public health effects of new opioid applications and rescinds a 2014 draft guidance on analgesics. The agency says it plans to “provide more targeted information in critical areas of development using a series of new draft guidances to speed development.”

With the new draft guidance, and a scheduled public meeting on Sept. 17, regulators hope they can bring balance to these questions. “The agency will consider the benefits and risks of proposed new opioid analgesics relative to other already approved opioid and non-opioid analgesics,” FDA Acting Commissioner Ned Sharpless and CDER Deputy Director Douglas Throckmorton said in a joint statement.

“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,” Sharpless and Throckmorton said.

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