Comments on FDA’s Opioid Risk-Benefit Guidance Highlight Misuse

August 23, 2019

Syneos Health offered some suggestions for the FDA’s draft guidance for drugmakers on assessing the risks and benefits of opioids, urging the agency to highlight prior opioid exposure, guidance on tapering use and proper disposal.

In written comments to the agency, the contract research organization said more pre-approval research needs to be done into alternative solutions to addictive drugs with strong adverse side effects and the potential for abuse before strong opioids go to market.

The FDA needs to “add prior exposure, a.k.a. opioid naïve or opioid-experienced” to the guidance, said Stephen Sun,  Syneos’ vice president of global operations. He also called for “guidance on how product should be properly tapered or discontinued, particularly for long-acting opioids or those used for chronic pain,” and guidance on disposal of products to help mitigate adverse effects.

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