Guideline on the clinical development of medicines for the treatment of pain released for public consultation
The European Medicines Agency has released a guideline on the clinical development of medicines intended for the treatment of pain for a six-month public consultation. This document merges and updates the current two guidelines on nociceptive and neuropathic pain.
Pain is mostly classified into two types: nociceptive and neuropathic. Nociceptive pain is defined as pain due to the activation of nociceptors, nerves that sense and respond to parts of the body suffering from damage. Neuropathic pain can be defined as pain arising as a direct consequence of a lesion or disease affecting the peripheral or central nervous system.
Since the publication of the current two guidelines on nociceptive and neuropathic pain, the different pathophysiological mechanisms and pathways at the origin of pain have become better understood. It now appears that in several conditions, the pain is mixed, with both nociceptive and neuropathic elements, such as cancer pain.
This guideline defines models of nociceptive and neuropathic pain that can be used for medicine development, as well as models of mixed pain.
The document provides guidance on the identification of target patient populations and on the design and duration of clinical trials, which applies to the study of both acute and chronic pain. It also gives advice on efficacy and safety endpoints that should be used for clinical investigation.
This guideline also provides specific guidance with regard to special populations, including children and the elderly.
The public consultation ends on 30 November 2013.