SBIR-STTR Award

This Small Business Innovation Research (SBIR) Phase I project is aimed at the development of an innovation which provides for ongoing, minimally invasive, discreet delivery of medications to the distal 1/3 of the rectum. The project is directed toward developing an optimized design and prototype of a rectal medication administration device (RMAD). Almost all patients lose the ability to swallow as they near death. Approximately 10% 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. 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. Rectal medical administration is an excellent, yet underutilized modality due to lack of an easy, discreet, and comfortable delivery option. The rectal medication administration device will solve all of these current problems with rectal medication delivery. The broader impact/commercial potential of this project goes beyond the scope of hospice and palliative care. For example, it is conceivable that the device could be used in various emergency situations for hydration and medication delivery, seizure control being one example. It is possible that every ambulance, military medic, or special-forces soldier could carry one for medication delivery or hydration. It would likely be used for the administration of retention enemas to relieve constipated patients, for administration of antibiotics for severe bowel infections, and numerous other applications. Cancer patients undergoing chemotherapy with severe nausea and vomiting could use the device for anti-nausea medication delivery at home. It is clear that advances in the field of hospice and palliative care are very important. In 2009 there were 1.6M patients in hospice in the US, growing at 11% per year. Close to 30% of Medicare dollars are spent in the last year of life. The RMAD has the potential to reduce hospital costs by over $500 million annually. The development of the rectal medication administration device by Hospi Corporation will have profound humanitarian and financial benefits both within the US and worldwide within the hospice arena and well beyond.

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.