Abstract :Abstract
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.