SBIR/STTR Award attributes
Project Summary Abstract The United States is in the midst of an opioid epidemicInmost recent estimatesmillion people met diagnostic criteria for opioid use disorderOUDIn that same yearAmericans died of opioid overdose an average ofpreventable deaths per dayOpioid agonist therapyOATsuch as buprenorphine naloxoneBUP NALcan reduce opioid overdose deaths by at leastdecrease opioid misuseand improve quality of lifeBecause of its proven efficacythe National Institute on Drug AbuseNIDAthe Substance Abuse and Mental Health Services AdministrationSAMHSAthe American Society of Addiction MedicineASAMand the American Academy of Addiction PsychiatryAAAPendorse the use of medication assisted therapy in the treatment of OUDPoor medication adherence is one of the main barriers to long term efficacy of OATOur aim is to substantially increase adherence to oral BUP NAL with Pillsya smart technology platform developed over the pastyears using principles of behavioral sciencemodern designand highly scalable wireless and mobile technologiesPillsy acts like a digital medication coachproviding education and reminders using a mobile apptext messagesand automated phone callsThe platform is built around a Bluetooth based smart pill bottle cap that automatically tracks dosestiming and sends intelligent reminders to create a unique feedback loopwhich allows us to constantly optimize our incentive reminder messages to meet user needs to increase adherenceA dashboard enables providers to easily medication use and patient engagementPillsy can substantially increase adherence to OAT and decrease opioid related morbidity and mortalitySince Pillsy only nominally increases the cost of oral BUP NAL treatment and physicians can bill for monitoring timeCPT codeit is an attractive solution to patientsphysiciansand payersIn Phase I of the Fast Track projectwe conduct qualitative interviews with OUD patients and providers that will guide the development of patient tailored messages and a physician specific dashboardWe will build out and adapt our current Pillsy platformthen test it in small scale trial to assess feasibilityusabilityand efficacyUsing the data obtained in Phase I and after meeting with the FDAwe will further refine the platform in Phase IIOnce completewe will perform a randomized efficacy trial in at leastpatients with OUDAt the end of this trial we will demonstrate that Pillsy significantly improves adherence to BUP NAL compared to service as usual as determined by mediation possession ratioin office urine drug screeningand patient selfreportSecondarilywe will show Pillsy decreases non prescribed opioid use and significantly increases treatment retentionThese results will be submitted to the FDA and will serve as the basis for broader commercialization marketing of Pillsy in the opioid use disorder Medication Assisted Treatment space Project Narrative Experts uniformly endorse the use of Medication Assisted TreatmentMATfor individuals struggling with opioid use disorder because it can reduce relapselower overall health care costsand save livesSadlymost patients do not successfully adhere to MATOur solution can greatly improve adherence to MATthereby helping people with opioid use disorder stay in treatmentstay cleanand stay alive
