SBIR Phase II: Optimized Medication Administration Device for Palliative Care

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to provide a clinically effective and discreet way to administer palliative medications cost effectively when the oral route is compromised. Almost all patients lose the ability to swallow as they near death. Approximately 10%-20% of hospice patients have severe symptoms after the oral route is no longer functional. Unfortunately most of these patients either die uncomfortably, or are admitted to the hospital for symptom control. These outcomes are tragic for the patient, and cost the healthcare system hundreds of millions annually. There are approximately 1.7M patients in hospice in the US per year. Close to 30% of Medicare dollars are spent in the last year of life. An approach enabling low acuity care that provides effective symptom control in the patient?s home can reduce Medicare hospice benefit costs by over $500 million annually. More importantly, it would enable patients to remain in their homes, with dignity, during the last precious days of life. Successful execution of this project would also result in a viable medical device business that would create dozens of new jobs supported by multi-million dollar revenues. The proposed project is directed toward developing an optimized version of a rectal medication administration device that can be placed by a layperson and is comfortable for the patient. The rectum is highly vascularized for rapid and effective absorption. The distal 1/3 of the rectum partially bypasses the hepatic portal vein allowing medication to enter the central venous system without a first pass effect through the liver. The rectal route does not have the complication risks or the cost of percutaneous medication administration. A pharmacokinetic study will be performed to compare the systemic absorption of palliative medication administered via micro-enema to the absorption via suppository. Suppositories are an undesirable way to administer ongoing medications rectally due to the discomfort and embarrassment of repeated insertions, as well as the wait time and cost associated with procuring medications in suppository form. Upon successful completion of Phase II work, prototypes of optimized devices will be complete and validated for ease of use in a usability study with layperson volunteers. The aim of the proposed project is to make the rectal route of medication administration practical, and thus set the stage to introduce its benefits to a broad segment of the patient population.