The EMA believes that clinical evaluations of paying me to be refined in order to better reflect the different kinds of pain been studied. Due to the subjective nature of pain and the problems associated with correct diagnosis patients are frequently undertreated acute and chronic situations. Whilst Noiceptive and neuropathic pain have been internationally defined the experience on clinical development has not been large.
The EMA believes the different types of pain may have different pathophysiological mechanisms and pathways which should be considered in the clinical development of new analgesic agents, and the proposed models to evaluate treatment efficacy should be updated in line of the experience gained during the past years.
excerpt from guidance
full text here
Pain is the most common symptom for which patients seek medical attention. Although there is no exact definition it has been defined as an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage (International Association for the Study of Pain (IASP). Due to the subjective component of pain and the problems associated with a correct diagnosis patients are frequently undertreated for acute and chronic situations.
Nociceptive and neuropathic pain has been internationally defined. Nociceptive pain can be defined as the process by which intense thermal, mechanical, or chemical stimuli are detected by a subpopulation of peripheral nerve fibers, called nociceptors whereas neuropathic pain can be defined as pain arising as a direct consequence of a lesion or disease affecting the somatosensory system. In addition, pain can be of mixed origin (e.g. cancer pain), thus justifying that the 2 current guidelines are merged in a unique document. When current guidelines on nociceptive and neuropathic pain were written, the experience on clinical development was not large.
The different types of pain which may have different pathophysiological mechanisms and pathways should be considered in the clinical development of new analgesic agents, and the proposed models to evaluate treatment efficacy should be updated in line of the experience gained during the past years.
Fibromyalgia is a complex disease with clinical features other than pain and should be dealt with in a separate document.
