Companies that are developing local anesthetic products intended to have a long-acting effect should collect trial data on “clinically meaningful outcomes,” such as reduction in hospitalization, even if such information is not sufficient to serve as the basis for approval, the US Food and Drug Administration said in a new draft guidance.
‘Clinically Meaningful Outcomes’ Data Urged For Long-Acting, Local Anesthetic Drug Products
Although a new FDA guidance recommends difference in pain scores as the primary efficacy endpoint for evaluation of postoperative analgesic effect, data on outcomes such as reduction in hospitalization and deaths from opioid abuse would be valuable and could provide a basis for inclusion in labeling; guidance is part of broader agency effort to reduce opioid use.
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