Translational pain biomarkers in the early development of new neurotherapeutics for pain management

Abstract

Translation of the analgesic efficacy of investigational neurotherapeutics from pre-clinical pain models into clinical trial phases is associated with a high risk of failure. Application of human pain biomarkers in early stages of clinical trials can potentially enhance the rate of successful translation, which would eventually reduce both length and costs of drug development after the pre-clinical stage. Human pain biomarkers are based on the standardized activation of pain pathways followed by the assessment of ongoing and paroxysmal pain, plus evoked responses which can be applied to healthy individuals and patients prior to and after pharmacological interventions. This review discusses the rationality and feasibility of advanced human pain biomarkers in early phases of drug development for pain management which is still an unmet medical need.

Keywords::

• analgesics
• clinical trials
• drug development
• human experimental models
• neurotherapeutics
• pain biomarkers
• translational

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending or royalties.

No writing assistance was utilized in the production of this manuscript.

Key issues

• It is obvious that a human experimental pain biomarker or surrogate models cannot represent a complex clinical chronic pain condition.

• But when used under standardized conditions, they can provide insights into the mode of action and predict an optimal clinical response.

• Depending on the stage of a new compound under development, different options exist for implementing the biomarkers.