The need for fundamental reforms in the pain research field to develop innovative drugs

ABSTRACT

Introduction: Chronic pain is a major healthcare issue owing to its high prevalence, significant physical and emotional burden on the patients, and huge financial burden on the society. The efficacy of currently available medications is unsatisfactory owing to their limited effect size and the low responder rate (less than 50%). Thus, there is a large unmet need for innovative therapies for chronic pain.

Areas covered: In this review, the author points out the need for fundamental reforms in pain research. For the last several decades, drug discovery research has extensively focused on designing new therapies using animal models of chronic pain. It has, however, made insufficient progress with respect to the launch of innovative analgesic drugs, because the translation from preclinical to clinical stages has not been satisfactory. Thus, the strategies for developing innovative analgesic drugs are discussed.

Expert opinion: Points to be considered in the discovery of drugs for pain relief include: (1) the exclusion of bias incorporation and the alignment of clinical and preclinical endpoints in the assessment of analgesic efficacy; (2) the understanding of primary unmet needs; (3) the assessment of new therapies by biomarker-prioritized frameworks, and (4) the stratification of chronic pain sufferers.

KEYWORDS:

• Fundamental change
• pain research
• bias
• endpoint alignment
• primary unmet need
• proof-of-efficacy biomarker
• patient stratification

Article highlights

• Drug discovery research in the field of pain, at present, is facing a major need for fundamental reform to develop innovative drugs in the future.

• The exclusion of the possibility of bias incorporation in the preclinical assessment is vital to ensure the reproducibility of the efficacy data.

• The pain component resistant to existing therapy should be more focused in the preclinical research based on the primary unmet need in the clinical chronic pain.

• The identification of proof-of-efficacy biomarkers for the assessment analgesic efficacy would be important to achieve the successful development of innovative drugs.

• The implementation of the personalised medicine approach is a strategic direction which the drug discovery research in the pain field should consider.

This box summarizes key points contained in the article.

Declaration of interest

The author has 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.

Additional information

Funding

This manuscript has not been funded.