Opioid-related overdoses and adverse events are a continuing national health concern. In the United States, prescription opioid use and deaths from overdose or opioid-induced respiratory depression have increased dramatically. Part of the opioid epidemic begins at the time of prescription. To date, there are no evidence-based, easy-to-use screening tools that assist healthcare professionals in making an informed clinical decision on whether or not to prescribe an opioid or how to mitigate associated overdose risks based on a patient’s unique comorbidity and medication profile.
A mid-size pharmaceutical company developed a drug-device combination product for the at-home administration of an opioid antagonist medication in the event of accidental overdose. In an overwhelmingly positive response from the FDA to its new drug application (NDA), the company was asked to expand the product’s indication. Venebio conducted a pharmacoepidemiologic analysis in support of expanding the patient base for the product. Together, Venebio and the company realized the value in expanding these preliminary results to develop a screening tool for patients at risk for overdose or serious opioid-induced respiratory depression.
Venebio assembled a team of experts with experience in developing clinical decision support systems (CDSS), as well as pain and addiction scientists who understand the nuances of this unique public health challenge. Venebio analyzed the risk factors for serious prescription opioid-related toxicity or overdose among Veteran’s Health Administration patients. From there, the team developed a predictive questionnaire and a risk index for prescription opioid-induced respiratory depressions or overdose. Once those parameters were established, an algorithm was developed, which served as the base of the CDSS. The tool went through the validation process in a commercial healthcare claims database to confirm the validity and success of its predictions in a variety of clinical settings and patient subgroups.
Once the predictive algorithm was created and validated, the CDSS was developed, filling a market void for a personalized, evidence-based, easy-to-implement risk reduction tool. Research supporting the CDSS tool, which went on to be named Venebio Opioid Advisor (VOA), was published in four peer-reviewed publications, and was presented at two prominent, pain-focused scientific meetings.
- Zedler B., L. Xie, L. Wang, A. Joyce, C. Vick, J. Brigham, F. Kariburyo, O. Baser, and E.L. Murrelle. Development of a Risk Index for Serious Prescription Opioid-Induced Respiratory Depression or Overdose in Veterans’ Health Administration Patients. Pain Medicine, 2015.
- Zedler B., L. Xie, L. Wang, A. Joyce, C. Vick, F. Kariburyo, P. Rajan, O. Baser, and L. Murrelle. Risk factors for serious prescription opioid-related toxicity or overdose among Veterans Health Administration patients. Pain Medicine, 2014.
- Nadpara P., A. Joyce, E.L. Murrelle, N.C. Carroll, N.V. Carroll, M. Barnard, B. Zedler. Risk factors for serious prescription opioid-induced respiratory depression or overdose: comparison of commercially insured and Veterans Health Affairs populations. Pain Medicine, 2017.
- Zedler B., W. Saunders, A. Joyce, C. Vick, and E.L. Murrelle. Validation of a screening risk index for serious prescription opioid-induced respiratory depression or overdose in a U.S. commercial health plan claims database. Pain Medicine, 2017.
All of the supporting research and deliverables from Venebio’s team helped to optimize the company’s market position. Commercialization continues for VOA as it is implemented into insurance databases, pharmacies, and clinical practices nationwide.
How Venebio addressed the challenge
The opioid, addiction, and pain issues that affect the United States aren’t going away any time soon. In addition to national awareness and crisis response, prevention is essential. When tasked with a project in this space, Venebio looked beyond what’s asked of its team to find new opportunities to create technologies that address broader public health issues.