Transdermal Hydromorphone for Acute and Chronic Pain

DESCRIPTION (provided by applicant): Founded in 1998, Altea Therapeutics is developing its PassPort(tm) system to deliver proteins and peptides, small-molecule drugs, genes and vaccines from a skin patch, eliminating the need for invasive needle injection. This breakthrough technology, currently undergoing Phase 1 clinical trials for basal insulin delivery, revolutionizes the way in which medicines can be administered, increasing efficacy, safety, and compliance. The overriding goal of this SBIR Phase II project is to develop and commercialize a novel skin patch for safe and efficient needle-free administration of hydromorphone for treatment of acute and chronic pain. In our SBIR Phase I work we were able to convincingly demonstrate that microporation of the stratum corneum by thermal ablation is highly effective in enabling the delivery of hydromorphone in vitro and in vivo (animal model). Herein we propose a series of FDA Phase 1 pharmacokinetic studies to establish steady-state therapeutic delivery profiles for 24 hours in human volunteers. The aim of these pharmacokinetic studies is to demonstrate rapid onset of therapeutic action, sustained and constant delivery rates for 24 hours and rapid clearance after patch removal. If successful, the resulting transdermal patch for delivery of hydromorphone promises significant and compelling patient benefits for treatment of acute and chronic pain including, but not limited to, improved convenience, therapeutic advantages, ease-of-use, and cost-effectiveness.