Sustained-Release Drug Delivery Device for Refillable Subcutaneous Implantation
Abstract
Poor adherence to many chronic medications reduces their effectiveness, discouraging patients during their treatment while adding burden to the physician and payer resources of the healthcare sector. The annual cost to the US of nonadherence with prescriptions is estimated to exceed $300 billion annually. Significant efforts have been made to solve this problem with sustained-release drug delivery technologies. However, despite billions of dollars spent in research and development over the past few decades, a simple and practical solution to support the long-term treatment of many diseases has not been found. The availability of a technology that meets this need would be transformative for patients, doctors, and payers, and it would offer a major improvement in the quality of life of patients who must take medication frequently. Of specific interest, and the topic of much national discussion today, is the opioid crisis facing many communities. According to recent estimates, there are 2.5 million people with opioid addiction in the US. Approximately 20 percent of this population is addicted to illicit opioids, such as heroin, and the other 80 percent to prescription opioids, such as oxycodone, hydrocodone, etc. This epidemic is ravaging communities and killing tens of thousands every year with both military personnel and Veterans at elevated risk. Recent efforts have attempted to treat opioid addiction using a drug called buprenorphine. A 2016 study has shown that buprenorphine improved the overlapping symptoms of post-traumatic stress, pain, and opioid use disorder in Veterans diagnosed with all three conditions. Existing treatment options range from oral medication to implantable rods, but these are non-optimal. While implantable rods provide for abuse-deterrence (as buprenorphine is also prone to abuse), they do not provide sufficient dosing to treat addiction. The commercialization of the product outlined in this proposal would allow an abuse-deterrent treatment paradigm that is patient-friendly, minimizing discomfort upon implantation and ensuring adherence to the prescription regimen. This project is addressing the Peer Reviewed Medical Research Program Topic Area and Area of Encouragement of Sustained-Release Drug Delivery with the goal of commercializing a novel device (nStrada™) that is implantable under the skin for long-term (> 6 months) drug delivery of multiple drugs. The project plan would take this development through a controlled process compliant with the requirement of the US Food and Drug Administration (FDA). This process will demonstrate how the proposed implant, based on patented nanotechnologies, will advance the product toward clinical trials while also validating the technology for broader application in the long-term delivery of drugs. The key capabilities, performance, and compatibility of the nStrada technology for both implantation and drug delivery have been demonstrated in numerous (>10) animal studies using rodents, dogs, mini-pigs, and monkeys significantly reducing the risk of the project. The nStrada is manufactured using the same materials and equipment as modern semiconductor components in computers, phones, etc., allowing the use of existing manufacturing capabilities for large-scale production at attractive costs. Furthermore, a special coating has been engineered that coats the surfaces and pathways of the device ensuring long-term durability when implanted in the body. This elegantly simple, passive system (no moving parts or power sources) functions like an hourglass where the drug molecules are like the sand grains of an hourglass streaming out at a constant rate. The project has been staged in three phases to develop the buprenorphine-nStrada combination product in accordance with regulatory requirements. Phase 1 focuses on commercial feasibility activities both for the formulation and for the device. In these activities, an optimal formulation for long-
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Oct 29, 2018
- Source ID
- W81XWH1810360
Entities
People
- Randal Goodall
Organizations
- NanoMedical Systems (United States)
- United States Army