‘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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Other expedited pathways like fast track, priority review or breakthrough could be appropriate, according to new draft guidance.
Keeping Track: US FDA Approves Heron’s Zynrelef In Post-Op Pain; Amgen/AZ Submit Tezepelumab For Severe Asthma
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Draft guidance says US FDA will consider product's benefit-risk balance relative to approved analgesics; it is particularly interested in comparative efficacy and safety data.