EMA consultation: Draft guideline on the clinical development of medicinal products intended for the treatment of pain
The European Medicines Agency (EMA) has released for public consultation a draft guideline on the clinical development of medicinal products intended for the treatment of pain.
What is this Guideline about?
The Guideline is intended to provide guidance on the clinical development of new medicinal products for the treatment of pain. It replaces and updates the separate guidelines on neuropathic (CPMP/EWP/252/03) and nociceptive pain (CPMP/EWP/612/00).
Why new guidelines now?
Pain syndromes have traditionally been divided into the aforementioned two categories of neuropathic and nociceptive pain, based on what seemed to be a clear mechanistic distinction. Many pain conditions can still be defined in such terms but in other cases, for chronic pain in particular, the distinction is not clear and this needs to be reflected in diagnostic, therapeutic and regulatory approaches.
The present document should be considered as a general guidance. The main requirements for the development of medicinal products for the treatment of pain with regard to study design, patient population and outcome measures are described. Specific issues, including difficult to treat chronic pain patients and other specific patient groups (children and elderly) are addressed.
How to answer to this consultation?
The document open for consultation is available by clicking here.
Please note that EPF will not submit a response, but our members are invited to do so. There are sections in the document for acute and chronic pain, cancer, fibromyalgia and other types of pain.
Comments should be provided using this template. The completed comments form should be sent to: email@example.com.
Please note that the deadline for comments for this guideline is Thursday 31 March 2016.