SafeMedWaste At-Home, Environmentally-Friendly Opioid Disposal Kit for Orthopedic Post-Operative Surgical Patients to Reduce Opioids Available for Diversion

Knee and shoulder surgery patients are at high risk of becoming addicted to opioids that are prescribed to manage pain after their surgery. Each year, from the 1.475 million knee/shoulder surgeries performed in the United States, an estimated 167,000 people, and another 17,000 of their friends and family, will become addicted to opioids. Limited options for

disposal of unused opioids, such as drug take-back locations, mixing with kitty litter or coffee grounds, and carbon-based home disposal kits, have low compliance and are hazardous to the environment. Most people will store their unused opioids in an unlocked cabinet or other unsecure areas, where diversion of the drugs is possible by friends and family.

Almost 50% of the 10.3 million people that misused opioids in 2018 started their path to addiction by accessing opioids that way. NIDA places the total economic burden of prescription opioid misuse in the US at $78.5 billion per year. Lifetime costs of opioid use disorder is estimated to be more than $250,000 per patient. If only 37 knee/shoulder

surgery patients that would have become addicted to opioids do not because they disposed of their drugs when no longer

needed, it could result in medical cost savings of $2+ million, over and above the modest cost of a drug disposal kit. There is

an urgent unmet medical need for a cost-effective, environmentally friendly, in-home opioid disposal solution for surgical patients that is clinically proven to reduce opioid use disorder and diversion and substantiated with economic data. Okra Medical has developed the patented SafeMedWaste in-home drug disposal container that meets that unmet

need. SafeMedWaste completely destroys opioids within minutes and can be placed in the regular trash, without risk of ground or municipal water contamination. In published side-by-side independent comparative studies, SafeMedWaste exceeded the performance measurements for destruction and leaching of other commercially available at-

home opioid disposal systems, none of which have published clinical evidence that they reduce the incidence of diversion or costs associated with opioid use disorder. In this Phase I SBIR project, Okra Medical will manufacture SafeMedWaste

under cGMP conditions. In collaboration with Prisma Health, a randomized pilot clinical trial will evaluate 300 patients 18-years of age and older in out-patient surgery clinics undergoing shoulder and knee surgery. The goal is to achieve 50% greater compliance with drug disposal at the end of 90 days in the treatment group compared to the control group.

Through pre- and post-surgery surveys, from correlations between patients’ attitude toward pain and pain management and

the reasons why they chose not to dispose of their drugs, we will build education for patients and clinicians to be validated

in future studies. The results of this work will enable us to conduct a larger multi-center human clinical trial in a Phase II application to demonstrate reduced opioid diversion and addiction, and their associated cost burden on our health system. The results will also support efficacy claims of reduced opioid use disorder and diversion for FDA clearance of

the device and reimbursement by payers of SafeMedWaste so that every patient that receives opioid pain medication following surgery can easily and safely dispose of their medication when no longer needed without paying out of pocket. Project Description Page 1 of 1