On June 10th, the FDA is convening a Public Meeting on Patient-Focused Drug Development for Neuropathic Pain Associated with Peripheral Neuropathy. The Agency is holding the meeting to address drug development needs and priorities for neuropathic pain associated with peripheral neuropathy.
Richard “Red” Lawhern, PhD emailed The National Pain Report over the weekend to urge people to participate (click here) and share with our readers what he is prepared to tell the FDA.
- For the long term, several experimental drugs or classes of drugs appear to offer potential for enhanced effectiveness in treating chronic pain due to peripheral neuropathy. One of these is CNV1014802, a novel small-molecule Sodium channel blocker specific to the Trigeminal Nerve. The drug was developed by Convergence Pharmaceuticals in the UK and completed Phase II Trials. Convergence was bought by a US company and the status of CNV1014802 is presently unclear. Further work on this agent needs to be accelerated and placed under close NINDS oversight. Authorization for use as an orphan drug should be accelerated.
- There are published early reports of effectiveness in pain control from use of Peptides found in spider venoms. Isolation of active agents and testing for safety and effectiveness in humans should receive priority funding.
- Despite the legal restrictions still placed on Marijuana, there is ample evidence in patient reports that several strains of this natural plant can be used effectively in pain management for a wide variety of chronic pain conditions including peripheral neuropathy. NIH funding is needed to bring this type of research out of the shadows and integrate it into mainstream medicine. If legislative changes are needed, then seek them soon.
- The most important near term outcome that this public meeting can reinforce is recognition that legally prescribed opioid medications play an indispensable role in present treatment of chronic neuropathic pain which is refractory to other therapies. In this context, the recently published CDC voluntary guidelines on prescription of opioids in adult chronic non-cancer pain need to be withdrawn immediately and rewritten to make this role clear — in both peripheral neuropathic pain and many other chronic pain conditions.
In their present form, the CDC guidelines have become a defacto restrictive practice standard that is driving doctors out of pain management, and thousands of patients into unmitigated agony. The basis for the guidelines is also scientifically weak and may have reflected professional or financial self-interest bias on the part of some participants in the Consultants Working Group that supported the writing. Insofar as I can determine, the working group did not include a SINGLE practicing Board Certified pain management specialist who is actively treating patients. Revisions of the guidelines need to reflect a much more patient-centered frame of reference, with explicit recognition that dose levels must be tailored to the individual patient and that effectiveness is highly variable between patients due to genetic factors which make some people poor metabolizers of this class of medication.