Journal
NEUROTHERAPEUTICS
Volume 6, Issue 4, Pages 749-754Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.nurt.2009.08.005
Keywords
Analgesics; clinical trials; biomarkers; sensory testing; capsaicin; heat; TRPV1; hyperalgesia
Funding
- National Institutes of Health [NS R01-41503]
- NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE [R01NS041503] Funding Source: NIH RePORTER
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The translation of analgesic efficacy seen in preclinical pain models into the clinic is problematic and is associated with a number of factors that may result in the failure of clinical trials to detect the effect of investigational therapeutic agents. The use of translational pain biomarkers in phase I trials can potentially reduce some of these risks by measuring the interaction between the drug and its target ( termed target engagement) in humans. To serve this purpose, sensory tests and other measures of pharmacological activity in nociceptive pathways need to be identified, based on the preclinical profile of the drug being tested and the feasibility of human assessments. Here we discuss some examples to assess the utility of sensory and related pain biomarkers in the early phase of evaluation of novel analgesics for confirmation of target engagement in humans. The emphasis is on the TRPV1 antagonists, but some other target mechanisms are also discussed in examining the validity of this approach.
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