Effectively controlled topical delivery of an innovative combination of targeted therapeutics to treat peripheral neuropathy

Peripheral Neuropathy (PN) is a painful debilitating condition caused by progressive subcutaneous nerve damage due to diabetes, chemotherapy or as a result of traumatic combat injuries. Current treatment options for PN are only moderately effective but have numerous drawbacks such as systemic effects, inefficient drug delivery and toxicity. Furthermore, long term use of some PN therapeutics can potentially lead to dependency. In Phase I, we obtained very strong in vitro proof-of-concept for our biocompatible epicutaneous gel system to non-invasively deliver a unique combination of targeted therapeutics transdermally, in a controlled and tailorable manner, to effectively treat peripheral neuropathy. Moreover, our approach was demonstrated in vitro to have the clear potential of both mitigating pain and blocking/limiting nerve damage due to PN. The epicutaneous gel can be easily administered due to its familiar topical gel format. In this proposed Phase II, an appropriate in vivo model of PN will be used to fully optimize our topical gel system for improved skin barrier penetration, optimal neuronal targeting ability and preclinical safety and efficacy, thereby setting the stage for eventual FDA clearance and commercialization. This innovative epicutaneous gel-based combination therapeutic system may significantly improve the quality of life of our soldiers with PN.