Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment

On 1 October 2020 the FDA announced the availability of the final guidance for industry.

This guidance is intended to help sponsors develop drugs for treatment of opioid use disorder (OUD). This guidance addresses clinical endpoints acceptable for demonstrating effectiveness of such drugs. This guidance does not address the development of drugs intended only to provide symptomatic relief of opioid withdrawal.

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