Opalgenix Inc

Reducing Opioid Use and Adverse Effects Through Proactive Precision Pain Management Following Spine Surgery - Project Summary Lumbar Spinal Surgery (LSS) Is a Common and Extremely Painful Surgery That Requires High Doses of Opioids for Long Duration to Manage Post-surgical Pain. Despite the Rise of Opioid Sparing Protocols and Multimodal Pain Management Techniques, Opioids Remain an Essential Component of Effective LSS Pain Management in the Hospital and at Home Following Discharge. 40% of LSS Patients Continue to Use Opioids Six Months Following Surgery. Post-operative Pain and Opioid-related Outcomes Vary Significantly Between Patients Based on Genetic and Other Clinical Risks Such as Preoperative Opioid Use. Perioperative Opioids Can Cause Unpredictable Adverse Effects Ranging From Poor Pain Relief, Postoperative Nausea and Vomiting (ponv), Respiratory Depression (RD), Dependence and Even Death, Due to Narrow Therapeutic Windows and Inter-individual Variations in Responses. Those With Poorly Controlled Acute Surgical Pain and Preoperative Opioid Use Are at Risk for Chronic Post-surgical Pain, Long-term Opioid Use and Opioid Addiction. Current Evidence Shows That 30-60% of Opioid-related Adverse Events Are Influenced by Genetic Factors, With Demographic and Clinical Attributes Adding Additional Risk Factors. Opalgenix Will Build on Our Extensive Prior Prospective Studies of Genetic and Clinical Predictors of Postoperative Pain and Opioid-related Adverse Outcomes to Develop and Commercialize Opalgenix’s Genotype-guided Physician Support for Opioid Use, Gps-opioidtm. Gps-opioid Will Be a Pre-operative 510(K) Cleared Medical Device Incorporating a Pharmacogenetic Panel and Intelligent Analytics to Provide Personalized Risk Analysis to Proactively Predict Opioid-related Risks for Supporting Clinical Decision for Personalized Pain Management and Opioid Dosing in Patients Undergoing LSS. the Phase I Portion of the Project Will Confirm Multiple and Biologically Relevant Candidate Genes and Variants in 200 Adult LSS Patients in a Prospective Observational Study and Develop Risk Prediction Algorithms That Innovatively Integrate Polygenetic, Clinical and Demographic Risks (e.g. Prior History of Opioid Use, Depression, Sleep Apnea) to Predict Personalized Risk for Opioid-induced RD, Ponv, Excessive Sedation, Severe Pain, Longer Hospital Stays, Chronic Post-surgical Pain (CPSP), Persistent Opioid Use, Cost of Care, Opioid Dependence and Opioid Use Disorder Risk at 3 Months. the Phase Ii Program Will Focus on Integrating the Clinical Risk Prediction Algorithms Into the Cerner Electronic Health Records Platform at University of Pittsburgh Medical Center, Followed by a Head-to-head Prospective Clinical Trial in 400 Adult LSS Patients to Compare Opioid and Pain Related Outcomes of LSS Patients That Receive Standard-of-care (N=200) to Those for Whom an Individualized Opioid Risk Report Is Delivered to the Anesthesiologists and Surgeons (N=200). Successful Completion of This Program Will Demonstrate Superior Performance of Gps-opioid Compared to Standard of Care and Position Opalgenix for Regulatory Approval of Its Risk Prediction Algorithm, Gps-opioid, as a Medical Device.