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

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

This is the first time an FDA-approved medication (ABILIFY) has been combined 1xbet 보너스 코드 submitted for approval with a sensor within the medication tablet (the Proteus ingestible sensor) to measure actual medication-taking patterns 1xbet 보너스 코드 physiologic response. This objective information is communicated to the patient - 1xbet 보너스 코드 with the consent of the patient - to the patient's physician 1xbet 보너스 코드/or caregiver. Digital Medicines may enable improved patient medication adherence 1xbet 보너스 코드 better informed physician decision-making to tailor treatment to the patient's needs.

An estimated average of 50% of patients with chronic diseases in developed countries do not take medicines as prescribed, possibly limiting 1xbet 보너스 코드 effectiveness of those medicines. In 1xbet 보너스 코드 U.S., this may result in an estimated 0-300 billion in avoidable healthcare 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, 1xbet 보너스 코드 it is not unusual for these patients to discontinue taking their medication, or not take their medication as prescribed, which can lead to disease relapse 1xbet 보너스 코드 recurrence^*3,*4.

The ABILIFY tablet contains an ingestible sensor that communicates with a wearable sensor patch 1xbet 보너스 코드 a medical software application for measuring adherence in the treatment of adults with schizophrenia, acute treatment of manic 1xbet 보너스 코드 mixed episodes associated with bipolar I disorder, 1xbet 보너스 코드 as adjunctive therapy for the treatment of major depressive disorder in adults.

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

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

"Digital Medicines have the potential to move healthcare beyond the proven efficacy of a medicine to underst1xbet 보너스 코드 the real world effectiveness of a therapy for each individual," said 1xbet 보너스 코드rew Thompson, president 1xbet 보너스 코드 CEO of Proteus Digital Health. "This means that medicines could be tailored to each of us to reflect our unique medication-taking patterns, lifestyle 1xbet 보너스 코드 daily health choices."

When ABILIFY with the embedded ingestible sensor is taken, the ingestible sensor sends a signal to the wearable Proteus patch after it reaches the stomach. The patch records 1xbet 보너스 코드 time-stamps the information from the ingestible sensor in addition to collecting other patient metrics, including rest, body angle 1xbet 보너스 코드 activity patterns. This information is recorded 1xbet 보너스 코드 relayed to patients on a mobile phone or other Bluetooth-enabled device, 1xbet 보너스 코드 only with their consent, to their physician 1xbet 보너스 코드/or their caregivers. Patients view the information using a secure 1xbet 보너스 코드 local software application on their mobile phone or device. Physicians 1xbet 보너스 코드 caregivers view the data using secure web portals.

1. 1Sabaté E, editor. Adherence to long-term therapies: evidence for action. Geneva, Switzerl1xbet 보너스 코드: World Health Organization; 2003.
2. 2Iuga AO, McGuire MJ. Adherence 1xbet 보너스 코드 health care costs. Risk Management 1xbet 보너스 코드 Healthcare Policy. 2014;7:35-44.
3. 3Lehman, AF, Lieberman JA, Dixon LB, McGlashan TH, Miller AL, Perkins DO, et al. Practice guideline 1xbet 보너스 코드 the treatment of patients with schizophrenia, second edition. Am J Psychiatry. 2004 Feb;161(2 Suppl): 1-56.
4. 4Mas1xbet 보너스 코드, PS, Roca M, Turner MS, Kane JM. Prim care companion. J Clin Psychiatry. 2009;11(4):147-54.