Feedback-regulated Naloxone Delivery Device to Prevent Opiate Overdose Deaths
(Fast-Track proposals will be accepted)
Number of Anticipated Awards: 1
Budget (total costs): Phase I: $150,000 for 6 months; Phase II: $1,000,000 for 2 years
It is strongly suggested that proposals adhere to the above budget amounts and project periods. Proposals with budgets exceeding the above amounts and project periods may not be funded.
Drug overdose is currently the second leading cause of unintentional death in the United States, second only to motor vehicles crashes. The population at risk for opioid overdose is diverse and includes, for example, more than 3% of U.S. adults currently receiving long-term opioid therapy for chronic noncancer pain, in addition to drug/substance abusing population. Opioids are now more often being prescribed for patients with moderate to severe pain.
Thus, effective measures that would prevent/avert opioid overdoses are needed as overdoses and death often occur inadvertently in private settings where no one is present to offer assistance. Furthermore, patients with opioid addiction are prone to overdose on injected opiates or on excessive oral doses of opioid medications. These overdoses also often happen when no help is available and patient’s lives are at risk.
The objective of this project is to develop an automated device that would administer standard doses of naloxone to a patient in overdose, thus reversing the effects of excess opiate. Naloxone has been used for decades in medical settings to avert opioid overdose, and recent pilot programs demonstrated the feasibility of proper use of naloxone by non-medical personnel. Patients expressing physiologic signals of opiate overdose (e.g. hypoxia, respiratory rate below a critical threshold for a critical period of time, etc.) could be administered an appropriate dose of naloxone even if unconscious. Due to the short duration of action of naloxone, the unit should be capable of repeating the injection after resetting itself and detecting another set of critical information.
There are more than 300,000 heroin users, nearly 5 million prescription opiate users, plus millions of chronic pain patients receiving end-of-life opiate analgesic pain care. The number of poisoning deaths and the percentage of these deaths involving opioid analgesics increase each year. From 1999 through 2006, the number of fatal poisonings involving opioid analgesics more than tripled from 4,000 to 13,800 deaths. Potentially, everyone who has been prescribed opioids, for pain or addiction, and heroin users, could be offered this device by their treatment provider who may be an addiction specialist, primary care physician or pain doctor. There is a crucial need to provide this device to these populations to prevent unintended overdose and deaths and to address public health need.
Phase I Activities and Expected Deliverables
Design the prediction algorithm for opioid overdose requiring the intervention and establish the endpoints for algorithm development
Design and assemble a prototype of detectors, injector and supporting hardware
Propose a strategy to prevent un-indicated use, such as in a person who is unresponsive due to the reasons other than an opioid overdose
Field-test the prototype with focus group participants.
Phase II Activities and Expected Deliverables
Conduct the initial clinical testing in appropriate user population which is sufficiently powered to adequately inform Phase II
Develop detailed plans for initial production model with cost projections
Plan regulatory approval strategy
Establish an FDA-compliant system
Conduct clinical testing necessary for FDA approval.