A Concept paper on the need for revision of Note for Guidance on Clinical Medicinal Products for Treatment of Nociceptive Pain and Guideline on clinical investigation of products intended for the treatment of neuropathic pain has been released by the EMA.
The document is intended to replace the ‘Note for Guidance on Clinical Investigation of Medicinal Products for Treatment of Nociceptive Pain’ and the ‘Guideline on clinical investigation of medicinal products intended for the treatment of neuropathic pain’, in order to elaborate a unique guideline updating the information on pain definition and evaluation, including the evaluation of pain in children.
In particular, the different types of pain which may have different pathophysiological mechanisms and pathways should be considered in the clinical development of new analgesic agents.
In the proposed update of the guidance document, the following issues will be discussed:
– Proposed models of nociceptive and neuropathic pain in humans
– Patient population
– Primary and secondary endpoints
– Data needed in children
– Psychological aspects
– Clinical safety evaluation.
Within the 31st of December, it is possible to send comments for the open consultation. Therefore, the Foundation proposes to collect comments to be sent to the European Commission. Send us your comments and/or proposals by e-mail at the address info@benzifoundation.org.