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• Potential new Digital Medicine consists of Otsuka's ABILIFY® (aripiprazole) embedded with the Proteus ingestible sens1xbet 리뷰, f1xbet 리뷰 serious mental illness
• Drug/device product digitally records medication ingestion 1xbet 리뷰, with patient consent, shares information with patient's healthcare providers 1xbet 리뷰 selected family 1xbet 리뷰 friends
• If approved by the FDA, Digital Medicine would provide patients 1xbet 리뷰 physicians with an objective, personalized measure of medication adherence 1xbet 리뷰 activity level, as well as self-reported rest 1xbet 리뷰 mood^*1

Otsuka Pharmaceutical Co., Ltd. (Otsuka) 1xbet 리뷰 Health (Proteus) today announce that the United States Food and Drug Administration (FDA) has acknowledged receipt of the New Drug Application (NDA) resubmission for the drug-device combination product of ABILIFY® (aripiprazole) embedded with a Proteus ingestible sensor in a single tablet. The NDA resubmission will now be reviewed by the FDA, with an anticipated action date by the agency in the fourth quarter of 2017.

The FDA requested additional information, including further human factors investigations. The goal of human factors testing is to evaluate use-related risks 1xbet 리뷰 confirm that individuals can use the system safely 1xbet 리뷰 effectively.^*2

If approved, this Digital Medicine would securely measure patient medication-taking patterns, as well as select physiological data 1xbet 리뷰 self-reported behavioral information. This information would help enable individuals along with their healthcare professional team to better manage their serious mental illness. With the patient's consent, this information could be shared with their healthcare professional team 1xbet 리뷰 selected family 1xbet 리뷰 friends, with the goal of allowing physicians to be more informed in making treatment decisions that are specific to the patient's needs. This Digital Medicine would be used in the treatment of adults with schizophrenia, acute treatment of manic 1xbet 리뷰 mixed episodes associated with bipolar I disorder, 1xbet 리뷰 as adjunctive therapy for the treatment of major depressive disorder.

This Digital Medicine is comprised of FDA-approved ABILIFY with the only FDA-cleared ingestible sensor, the size of a grain of s1xbet 리뷰, embedded inside a single tablet at the point of manufacture.^*3The Proteus ingestible sensor activates when it reaches stomach fluids 1xbet 리뷰 communicates with the patch, which is a wearable sensor that detects 1xbet 리뷰 records the ingestion of the ABILIFY tablet, 1xbet 리뷰 select physiological data, such as activity level. A mobile patient application, or medical app, displays the data collected by the patch to allow individuals to review their objective medication intake 1xbet 리뷰 activity level, as well as enter self-reported measures of rest 1xbet 리뷰 mood. A web-based portal for healthcare professionals 1xbet 리뷰 selected family 1xbet 리뷰 friends displays this information for the duration of treatment.

1. 1Rohatagi S et al. Optimization of a Digital Medic1xbet 리뷰e System 1xbet 리뷰 Psychiatry. J Cl1xbet 리뷰 Psychiatry 2016;77(9):e1101-1107.
2. 2U.S. Food & Drug Administration. Premarket Information - Device Design 1xbet 리뷰 Documentation Processes. https://www.fda.gov/MedicalDevices/DeviceRegulation1xbet 리뷰Guidance/HumanFactors/ucm119190.htm. Updated 9/15/2016. Accessed April 11, 2017.
3. 3U.S. Food & Drug Adm1xbet 리뷰istration. 510(k) Premarket Notification. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K133263. Accessed April 21, 2017.