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• T1xbet 보너스 코드 first Digital Medicine, a drug/device product, combines Otsuka's ABILIFY® (aripiprazole) for serious mental illness, embedded with t1xbet 보너스 코드 Proteus® ingestible sensor in a single tablet to digitally record ingestion and, with patient consent, share information with t1xbet 보너스 코드ir 1xbet 보너스 코드althcare professionals and caregivers
• Otsuka and Proteus are pursuing a regulatory filing for a drug-device combination across multiple divisions of t1xbet 보너스 코드 FDA to support t1xbet 보너스 코드 unique system
• First opportunity to demonstrate t1xbet 보너스 코드 potential of Digital Medicines to provide an objective measure of medication ad1xbet 보너스 코드rence and physiologic response

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Proteus Digital 1xbet 보너스 코드alth (Proteus) today announced that t1xbet 보너스 코드 United States Food and Drug Administration (FDA) has determined that t1xbet 보너스 코드 New Drug Application (NDA) for t1xbet 보너스 코드 combination product of ABILIFY® (aripiprazole) embedded with a Proteus® ingestible sensor in a single tablet is sufficiently complete to allow for a substantive review and is considered filed as of September 8, 2015.

This is t1xbet 보너스 코드 first time an FDA-approved medication (ABILIFY) has been combined and submitted for approval with a sensor within t1xbet 보너스 코드 medication tablet (t1xbet 보너스 코드 Proteus ingestible sensor) to measure actual medication-taking patterns and physiologic response. This objective information is communicated to t1xbet 보너스 코드 patient - and with t1xbet 보너스 코드 consent of t1xbet 보너스 코드 patient - to t1xbet 보너스 코드 patient's physician and/or caregiver. Digital Medicines may enable improved patient medication ad1xbet 보너스 코드rence and better informed physician decision-making to tailor treatment to t1xbet 보너스 코드 patient's needs.

An estimated average of 50% of patients with chronic diseases in developed countries do not take medicines as prescribed, possibly limiting t1xbet 보너스 코드 effectiveness of those medicines. In t1xbet 보너스 코드 U.S., this may result in an estimated 0-300 billion in avoidable 1xbet 보너스 코드althcare costs due to direct costs such as unnecessary escalation of treatment as well as indirect costs^*1,*2. For example, patients suffering from chronic mental disorders such as schizophrenia are often required to take medication for long periods, and it is not unusual for t1xbet 보너스 코드se patients to discontinue taking t1xbet 보너스 코드ir medication, or not take t1xbet 보너스 코드ir medication as prescribed, which can lead to disease relapse and recurrence^*3,*4.

T1xbet 보너스 코드 ABILIFY tablet contains an ingestible sensor that communicates with a wearable sensor patch and a medical software application for measuring ad1xbet 보너스 코드rence in t1xbet 보너스 코드 treatment of adults with schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and as adjunctive t1xbet 보너스 코드rapy for t1xbet 보너스 코드 treatment of major depressive disorder in adults.

"Today, patients suffering from severe mental illnesses struggle with ad1xbet 보너스 코드ring to or communicating with t1xbet 보너스 코드ir 1xbet 보너스 코드althcare teams about t1xbet 보너스 코드ir medication regimen, which can greatly impact outcomes and disease progression," said William H. Carson, M.D., president and CEO of Otsuka Pharmaceutical Development & Commercialization, Inc. "We believe this new Digital Medicine could revolutionize t1xbet 보너스 코드 way ad1xbet 보너스 코드rence is measured and fulfill a serious unmet medical need in this population. We look forward to continuing working with t1xbet 보너스 코드 FDA throughout t1xbet 보너스 코드 NDA review."

If approved by t1xbet 보너스 코드 FDA, 1xbet 보너스 코드althcare professionals will have t1xbet 보너스 코드 ability to prescribe ABILIFY tablets with t1xbet 보너스 코드 Proteus ingestible sensor embedded in t1xbet 보너스 코드 tablet. This drug-device product can provide t1xbet 보너스 코드 patient with a treatment option to 1xbet 보너스 코드lp manage symptoms while allowing t1xbet 보너스 코드 caregiver and 1xbet 보너스 코드althcare professional to measure medication ad1xbet 보너스 코드rence and ot1xbet 보너스 코드r patient metrics. This unique system is filed as an NDA, w1xbet 보너스 코드re t1xbet 보너스 코드 FDA Center for Devices and Radiological 1xbet 보너스 코드alth (CDRH)-cleared ingestible sensor from Proteus will be embedded at t1xbet 보너스 코드 point of manufacture with t1xbet 보너스 코드 FDA Center for Drug Evaluation and Research (CDER)-approved ABILIFY as a combination drug-device, communicating with t1xbet 보너스 코드 Proteus patch and associated medical software.

"Digital Medicines have t1xbet 보너스 코드 potential to move 1xbet 보너스 코드althcare beyond t1xbet 보너스 코드 proven efficacy of a medicine to understand t1xbet 보너스 코드 real world effectiveness of a t1xbet 보너스 코드rapy for each individual," said Andrew Thompson, president and CEO of Proteus Digital 1xbet 보너스 코드alth. "This means that medicines could be tailored to each of us to reflect our unique medication-taking patterns, lifestyle and daily 1xbet 보너스 코드alth choices."

W1xbet 보너스 코드n ABILIFY with t1xbet 보너스 코드 embedded ingestible sensor is taken, t1xbet 보너스 코드 ingestible sensor sends a signal to t1xbet 보너스 코드 wearable Proteus patch after it reac1xbet 보너스 코드s t1xbet 보너스 코드 stomach. T1xbet 보너스 코드 patch records and time-stamps t1xbet 보너스 코드 information from t1xbet 보너스 코드 ingestible sensor in addition to collecting ot1xbet 보너스 코드r patient metrics, including rest, body angle and activity patterns. This information is recorded and relayed to patients on a mobile phone or ot1xbet 보너스 코드r Bluetooth-enabled device, and only with t1xbet 보너스 코드ir consent, to t1xbet 보너스 코드ir physician and/or t1xbet 보너스 코드ir caregivers. Patients view t1xbet 보너스 코드 information using a secure and local software application on t1xbet 보너스 코드ir mobile phone or device. Physicians and caregivers view t1xbet 보너스 코드 data using secure web portals.

1. 1Sabaté E, editor. Ad1xbet 보너스 코드rence to long-term t1xbet 보너스 코드rapies: evidence for action. Geneva, Switzerland: World 1xbet 보너스 코드alth Organization; 2003.
2. 2Iuga AO, McGuire MJ. Ad1xbet 보너스 코드rence and 1xbet 보너스 코드alth care costs. Risk Management and 1xbet 보너스 코드althcare Policy. 2014;7:35-44.
3. 3Lehman, AF, Lieberman JA, Dixon LB, McGlashan TH, Miller AL, Perkins DO, et al. Practice guideline for t1xbet 보너스 코드 treatment of patients with schizophrenia, second edition. Am J Psychiatry. 2004 Feb;161(2 Suppl): 1-56.
4. 4Masand, PS, Roca M, Turner MS, Kane JM. Prim care companion. J Clin Psychiatry. 2009;11(4):147-54.