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- Title
Designing development programs for non-traditional antibacterial agents.
- Authors
Rex, John H.; Fernandez Lynch, Holly; Cohen, I. Glenn; Darrow, Jonathan J.; Outterson, Kevin
- Abstract
In the face of rising rates of antibacterial resistance, many responses are being pursued in parallel, including 'non-traditional' antibacterial agents (agents that are not small-molecule drugs and/or do not act by directly targeting bacterial components necessary for bacterial growth). In this Perspective, we argue that the distinction between traditional and non-traditional agents has only limited relevance for regulatory purposes. Rather, most agents in both categories can and should be developed using standard measures of clinical efficacy demonstrated with non-inferiority or superiority trial designs according to existing regulatory frameworks. There may, however, be products with non-traditional goals focused on population-level benefits that would benefit from extension of current paradigms. Discussion of such potential paradigms should be undertaken by the development community. Non-traditional antibacterial agents are challenging to develop. In this Perspective, the authors argue that the distinction between traditional and non-traditional agents has only limited relevance for regulatory purposes, although products with non-traditional goals focused on population-level benefits might benefit from extension of current paradigms.
- Subjects
ACETOMYCIN; AUREOMYCIN; BACTERIOCINS; CIRCULIN; GROWTH
- Publication
Nature Communications, 2019, Vol 10, Issue 1, pN.PAG
- ISSN
2041-1723
- Publication type
Article
- DOI
10.1038/s41467-019-11303-9