SBIR-STTR Award

The American Medical Association reports that undertreatment of pain is a major problem for cancer patients as well as for other disease conditions. Approximately 50-75% of cancer patients have pain that is undertreated, and 25% die in severe unrelieved pain. Noninvasive pain medication delivery systems are ideally suited to improve the quality of life for those who experience chronic pain. Currently available noninvasive systems are slow, variable, or require frequent dosing. The goal of this project is to demonstrate the capability of a novel thermal microporation method to enable rapid infusion of pain medication through the skin. The microporation method is a noninvasive, painless, needless, patch-based system which creates an array of microscopic openings in the stratum corneum that increases the drug flux significantly compared to drugs delivered through intact skin. Four top opioid candidates for microporation delivery will be evaluated with an in vitro drug delivery model system that involves studying freshly harvested hairless mouse skin to determine optimal formulation and microporation delivery parameters. The opioid candidates to be tested in vitro with the thermal microporation method include morphine, hydromorphone, fentanyl, and alfentanil. A small pilot clinical study will also be performed to determine the feasibility of delivering fentanyl with a commercially available transdermal patch in conjunction with the microporation system.

Thesaurus Terms:
analgesic, cancer pain, drug delivery system, drug design /synthesis /production, electroporation, opiate alkaloid, technology /technique development morphine clinical research, human subject, laboratory mouse

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.