Guidance for Industry

Analgesic Indications: Developing Drug and Biological Products


February 2014 Clinical/Medical

This guidance provides recommendations to sponsors on the development of prescription drugs that are the subject of new drug applications (NDAs) for the management of acute and chronic pain as well as the management of breakthrough pain (hereafter analgesic development).

Specifically, this guidance focuses on clinical drug development and trial design issues and chemistry, manufacturing, and controls (CMC) concerns that are unique to the study of acute, chronic, and breakthrough pain and the labeling considerations for analgesic drugs.

This draft guidance is intended to serve as a focus for continued discussions on relevant issues among the Division of Anesthesia, Analgesia, and Addiction Products, pharmaceutical sponsors, the academic community, and the public.

This guidance does not discuss nonclinical drug development, because we have not identified nonclinical concerns unique to analgesic development.  This guidance does not specifically address all syndromes in which pain is a component such as dysmenorrhea, migraines, or irritable bowel syndrome. Sponsors seeking to develop drugs for these syndromes should consult with the appropriate review division. This guidance also does not discuss general issues related to statistical analysis or clinical trial design. Those topics are addressed in the ICH guidances for industry E9 Statistical Principles for Clinical Trials and E10 Choice of Control Group and Related Issues in Clinical Trials, respectively.

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Last Updated: 2016-05-30

Analgesic Indications: Developing Drug and Biological Products
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