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WO 2018/035147 Al 22 February 2018 (22.02.2018) W !P O PCT

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WO 2018/035147 Al 22 February 2018 (22.02.2018) W !P O PCT (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2018/035147 Al 22 February 2018 (22.02.2018) W !P O PCT (51) International Patent Classification: (74) Agent: WORD, Michael, J.; Mayer Brown LLP, P.O. Box G06F 17/00 (2006.01) 2828, Chicago, IL 60690-2828 (US). (21) International Application Number: (81) Designated States (unless otherwise indicated, for every PCT/US20 17/046997 kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, (22) International Filing Date: CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, 15 August 2017 (15.08.2017) DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, (25) Filing Language: English HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, (26) Publication Langi English MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, (30) Priority Data: OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, 62/375,256 15 August 2016 (15.08.2016) US SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, 62/375,192 15 August 2016 (15.08.2016) US TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. 62/416,972 03 November 2016 (03 .11.20 16) US (84) Designated States (unless otherwise indicated, for every 62/427,919 30 November 2016 (30. 11.2016) US kind of regional protection available): ARIPO (BW, GH, 62/432,248 09 December 20 16 (09. 12.20 16) US GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, 62/432,358 09 December 20 16 (09. 12.20 16) US UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, 62/432,292 09 December 20 16 (09. 12.20 16) US TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, 62/432,394 09 December 20 16 (09. 12.20 16) US EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, PCT/US20 17/0 17665 MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, 13 February 2017 (13.02.2017) US TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, (72) Inventor; and KM, ML, MR, NE, SN, TD, TG). (71) Applicant: VALENTINE, Edmund, L. [US/US]; C/o 439 Savoie Drive, Palm Beach Gardens, FL 33410 (US). Published: — with international search report (Art. 21(3)) (54) Title: DRUG AND DEVICE COMBINATION PRODUCTS WITH IMPROVED SAFETY AND EFFICACY PROFILES (57) Abstract: The present invention describes a novel oral drug dispensing sy s tem comprised of a mobile Drug Specific App which utilizes a patient and drug specific drug dispensing algorithm which incorporates the use of digitally cap tured and patient self-assessment, self-test, and/or self- report, prescription, and dispenser information/values to; (i) control drug dispensing to improve medica tion safety, (ii) personalize oral drug therapy, (iii) improve medication effective ness while avoiding drug mediated side effects, (iv) decreases misuse, abuse, over dosing, under dosing, dependence, addiction, divergence, accidental ingestion, overdose, and deaths, (v) improve disease management, (vi) ensure prescription compliance, and (vii) promotes prescription persistence on a cost-effective re al-time basis. DRUG AND DEVICE COMBINATION PRODUCTS WITH IMPROVED SAFETY AND EFFICACY PROFILES CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims benefit of U.S. Provisional Patent Application No. 62/375,192 filed on August 15, 2016; U.S. Provisional Patent Application No. 62/375,256 filed on August 15, 2016; U.S. Provisional Patent Application No. 62/416,972 filed on November 3, 2016; U.S. Provisional Patent Application No. 62/427,919 filed on November 30, 2016; U.S. Provisional Patent Application No. 62/432,292 filed on December 9, 2016; U.S. Provisional Patent Application No. 62/432,248 filed on December 9, 2016; U.S. Provisional Patent Application No. 62/432,358 filed on December 9, 2016; U.S. Provisional Patent Application No. 62/432,394 filed on December 9, 2016, and International Patent Application No. PCT/US 17/1 7665 filed on February 13, 2017, each of which are incorporated herein by reference in their entirety to the full extent permitted by law. FIELD OF THE INVENTION [0002] The present disclosure relates to a novel system, each independent component which brings a unique attribute, that together as a drug and device combination product improves the drug's safety profile and deters/decreases drug overdoses, misuse, abuse, accidental ingestion, and drug divergence. Each drug and device combination product is comprised of a drug, an interrelated Drug Specific and Patient Tailored App™, an overdose diagnostic (OverDoseScreen™), drug specific and patient tailored dispensing algorithm, drug dispenser, drug cassette, electronic data exchange, and certain integrated support services. The closed loop system is designed to decrease drug diversion, misuse, abuse, addiction, dependence, overdose, accidental ingestion and deaths - thereby improving the quality of care, enhancing the patient's quality of life, and decreasing the total cost of care by minimizing the number of drug related medical interventions, emergency room visits, and hospitalizations. Together with patient biometric and monitoring data, such as may be provided through an IoT device in communication with the he closed loop system may also have the benefits of optimizing the required dose, minimizing over prescribing and under prescribing. BACKGROUND OF THE INVENTION [0003] Deterring drug divergence, misuse, decreasing the incidence of drug addiction and dependence, avoiding drug overdoses and deaths, decreasing the incidence of accidental ingestion of drugs by children, properly titrating and dosing patients, optimizing treatment, effectively managing drug tolerance, avoiding unnecessary drug induced side effects, and ensuring patient prescription compliance, and controlling drug withdrawal represent major unmet needs. [0004] One specific example of such unmet needs is with respect to opioid drugs. According to the United Nations Office on Drugs and Crime (UNODC), drug overdose is the top cause of drug-related deaths in the world, and opioids are the top drug type associated with those deaths. Drugs are derived from opium, which comes from opium poppy seeds. In general, the term opioid is used to refer to synthetic prescription painkillers, but heroin is also an opioid. The following are commonly prescribed opioids with example brand names of established and new products: (i) Oxycodone (OxyContin ®), (ii) Hydrocodone (Vicodin ®), (iii) Morphine, (iv) Buprenorphine, (v) Hydromorphone (Dilaudid ®), (vi) Oxymorphone (Opana®), Tapentadol, (vii) Tramadol (Ultram ®), (viii) Fentanyl (Duragesic ®), methadone (Dolophine ®), Morphine Sulfate and Naltrexone Hydrochloride (Embeda ®), Oxycodone Hydrochloride and Naltrexone Hydrochloride (Troxyca ® ER), etc. [0005] The World Health Organization (WHO) estimated that 16.4 million people used opioids in 2012. People who take prescription painkillers can become addicted with just one prescription. Once addicted, it can be hard to stop. According to the National Institute on Drug Abuse (NIDA), combined with their highly-addictive nature, opioids are dangerous because a single large dose can cause severe respiratory depression and death. In addition, a drug user's tolerance to opioids decreases during breaks from drug use. When they take the drug at the same dose as they did before a break, it often leads to an overdose. [0006] According to the International Narcotics Control Board (INCB), North America consumes 80 percent of the world's opioids, and has the highest rate of drug-related deaths in the world. IMS Health reported that Americans accounted for 99 percent of the world's hydrocodone (Vicodin®) consumption, 80 percent of the world's oxycodone (Percocet® and Oxycontin®) consumption and 65 percent of the world's hydromorphone (Dilaudid®) consumption in 2014. [0007] The United States' opioid statistics are alarming: a . According to the National Institute of Drug Abuse, opioid abuse is an epidemic in the United States, with about five (5) percent of the adult population using opiate pain medications non-medically. In 2015, approximately 12.5 million people misused prescription pain relievers in the past year, representing 4.7 percent of the population aged 12 or older. 1 Prescription Drug Use and Misuse in the United States: Results from the 2015 National Survey on Drug Use and Health, SAMHSA: Arthur Hughes, Matthew R . Williams, Rachel N . Lipari, and Jonaki Bose; RTI International: Elizabeth A . P. Copello and Larry A . Kroutil, September 2016. b. Major causes of preventable death - like car accidents - have been on the decline, but deaths from drug abuse doubled in the last decade (Deaths by overdoses involving prescription painkillers quadrupled since 1999.). More people die from overdoses of prescription opioids than from all other drugs combined, including heroin and cocaine. 2 In 2014, there were 18,893 overdose deaths related to prescription pain relievers - 52 people per day.3 Drug painkillers are the leading cause of accidental death. c . In 2015, 2.1 million people aged 12 or older were recent initiates for pain reliever misuse (i.e., misused for the first time in the past year), an average of 5,753 per day.4 d . In 2015, 2.0 million people had a pain reliever use disorder; e . Most adolescents who misuse prescription pain relievers are given them for free by a friend or relative. 5 f. In 2014, 467,000 adolescents, aged 12 to 17, were current nonmedical users of pain relievers, with 168,000 having an addiction to prescription pain relievers. 6 2 National Institute of Drug Abuse. (2015). Drug Facts: Prescription and Over-the-Counter Medications.
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