Antibacterial drug development: challenges, recent developments, and future considerations

S Nambiar; K Laessig; J Toerner; J Farley; E Cox

doi:10.1038/clpt.2014.116

Antibacterial drug development: challenges, recent developments, and future considerations

Clin Pharmacol Ther. 2014 Aug;96(2):147-9. doi: 10.1038/clpt.2014.116.

Authors

S Nambiar¹, K Laessig¹, J Toerner², J Farley², E Cox²

Affiliations

¹ Division of Anti-Infective Products, US Food and Drug Administration, Silver Spring, Maryland, USA.
² Office of Antimicrobial Products, US Food and Drug Administration, Silver Spring, Maryland, USA.

PMID: 25056394
DOI: 10.1038/clpt.2014.116

Abstract

A decline in antibacterial drug development coupled with emerging bacterial resistance has resulted in limited treatment options. One of the challenges facing antibacterial drug development is appropriate clinical trial designs. Noninferiority trials are appropriate to study new antibacterial drugs for the treatment of serious diseases; superiority trials can be challenging and cannot be the only acceptable trial design to study antibacterial drugs. Our efforts must continue to make new therapies available to meet patient needs.

Publication types

Review

MeSH terms

Animals
Anti-Bacterial Agents / chemistry
Anti-Bacterial Agents / pharmacology
Anti-Bacterial Agents / therapeutic use*
Bacterial Infections / drug therapy*
Bacterial Infections / epidemiology
Clinical Trials as Topic / methods
Clinical Trials as Topic / trends
Drug Discovery / methods
Drug Discovery / trends*
Drug Resistance, Multiple, Bacterial / drug effects*
Drug Resistance, Multiple, Bacterial / physiology
Forecasting
Humans

Substances

Anti-Bacterial Agents