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

膝盖和肩部手术患者对阿片类药物上瘾的风险很高，阿片类药物是用来治疗术后疼痛的处方。 他们的手术。每年，在美国进行的147.5万例膝盖/肩部手术中，估计 167,000人及其另外17,000名朋友和家人将对阿片类药物上瘾。有限的选项 处置未使用的类阿片，如毒品回收地点、与猫砂或咖啡渣混合以及碳基 家庭处理包，合规性低，对环境有害。大多数人都会把没用过的 在没有上锁的柜子里或其他不安全的地方存放阿片类药物，朋友和家人可以在那里转移毒品。 在2018年滥用阿片类药物的1030万人中，近50%的人是通过接触阿片类药物开始上瘾的 往那边走。NIDA认为，在美国，处方阿片类药物滥用造成的总经济负担为每年785亿美元。 据估计，每个患者一生中阿片类药物使用障碍的成本超过25万美元。如果只有37膝/肩 本来会对阿片类药物上瘾的外科患者不会这样做，因为他们在不再使用药物时会丢弃药物 如果需要，它可以节省200多万美元的医疗成本，这超出了药物处置工具包的适度成本。的确有 迫切需要一种经济高效、环境友好的家庭阿片类药物处理解决方案，用于外科手术 临床证明可以减少阿片类药物使用障碍和转移，并有经济数据证实的患者。 秋葵医疗公司开发了专利SafeMedWaste家用药物处理容器，满足了这一未满足的要求 需要。SafeMedWaste在几分钟内完全销毁阿片类药物，可以被放入常规垃圾桶，而不需要 地下水或城市水受到污染的风险。在已发表的并列独立比较研究中， SafeMedWaste超过了对其他商业可用废物的销毁和浸出性能测量- 家庭阿片类药物处置系统，没有一个发表临床证据表明它们减少了转移或 与阿片类药物使用障碍相关的成本。在第一阶段SBIR项目中，Okra Medical将生产SafeMedWaste 在cGMP条件下。与Prisma Health合作，一项随机试点临床试验将评估300名患者18 年及以上在接受肩部和膝部手术的门诊外科诊所就诊。目标是达到50% 治疗组90d末的药物处置依从性明显高于对照组。 通过手术前和手术后的调查，从患者对疼痛的态度和疼痛管理与 他们选择不处理他们的药物的原因，我们将为患者和临床医生建立教育以得到验证 在未来的研究中。这项工作的结果将使我们能够在第二阶段进行更大规模的多中心人体临床试验 申请证明减少阿片类药物的转移和成瘾及其对我们健康的相关成本负担 系统。这些结果还将支持减少阿片类药物使用障碍和转移FDA清除阿片类药物的疗效主张 SafeMedWaste的设备和付款人的报销使每个接受阿片类止痛药的患者 手术后，当不再需要时，可以轻松安全地处理他们的药物，而无需自掏腰包。 项目说明第1页，共1页

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