Jan M. Keppel Hesselink1*, Jeroen K. Mulder2 and David J. Kopsky3
1Institute for Neuropathic Pain, Netherlands
2Mulder Regulatory Expertise, Netherlands
3Institute for Neuropathic Pain, Netherlands
Drug repositioning is recognized as a dynamic field of drug development that can offer real benefits to patients, and it refers to the process of finding new uses for existing drugs outside the scope of the originally authorized medical indication. One key obstacle for the registration of repositioned drugs is the fact that old drugs are off-patent and therefore pharmaceutical industries will not invest in the development of new indications for these drugs because there is no financial incentive for such development. The development of an old drug for a new indication therefore needs to be performed by non-commercial parties, such as medical doctors (ideally as part of a network of experts) or academic groups. Based on external regulatory advice and after consultation with competent authorities, they then become the architects of a development plan. This paper will outline some fundaments for such investigator-driven development for a new compounded formulation containing phenytoin in the indication peripheral neuropathic pain, and suggests a solution for funding of such a development.
Topical; Repurposing; Personalized medicine; Neuropathy; Analgesia
Keppel Hesselink JM, Mulder JK, Kopsky DJ. Rationale for the Repositioning of Phenytoin as a Topical Analgesic for Peripheral Neuropathic Pain and a Personalized and Investigator-Driven Development Plan. Ann Pharmacol Pharm. 2018; 3(2): 1144.