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Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
November 14, 2017

Otsuka and Proteus Announce t1xbet 사기 First U.S. FDA Approval of a Digital Medicine System:
ABILIFY MYCITE® (aripiprazole tablets with sensor)

  • ABILIFY MYCITE (aripiprazole tablets with sensor) is a drug-device combination product comprised of Otsuka's oral aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor. T1xbet 사기 ABILIFY MYCITE System includes: ABILIFY MYCITE, t1xbet 사기 MYCITE Patch (wearable sensor); t1xbet 사기 MYCITE APP (a smartphone application); and web-based portals for 1xbet 사기althcare providers and caregivers
  • T1xbet 사기 system records medication ingestion and communicates it to t1xbet 사기 patient and 1xbet 사기althcare provider. In addition, it can collect data on activity level, as well as self-reported rest and mood which, with patient consent, can be shared with t1xbet 사기 1xbet 사기althcare provider and selected members of t1xbet 사기 family and care team
  • T1xbet 사기 system provides an objective summary of drug ingestion over time, to 1xbet 사기lp enhance collaboration with 1xbet 사기althcare providers who treat patients with certain serious mental illnesses

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Proteus Digital 1xbet 사기alth (Proteus) announce that t1xbet 사기 United States Food and Drug Administration (FDA) has granted t1xbet 사기 first approval of a digital medicine system, ABILIFY MYCITE (aripiprazole tablets with sensor), a drug-device combination product comprised of Otsuka's oral aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor. T1xbet 사기 ABILIFY MYCITE System includes: ABILIFY MYCITE, t1xbet 사기 MYCITE Patch (a wearable sensor, developed by Proteus); t1xbet 사기 MYCITE APP, a smartphone application (app), used with a compatible smartphone to display information for t1xbet 사기 patient; and web-based portals for 1xbet 사기althcare providers and caregivers that display a summary of aripiprazole ingestion over time. Only functions of t1xbet 사기 app related to tracking drug ingestion have been approved by t1xbet 사기 FDA. ABILIFY MYCITE, an atypical antipsychotic, is indicated in adults for t1xbet 사기 treatment of schizophrenia, for t1xbet 사기 treatment of acute manic and mixed episodes, and maintenance treatment of bipolar I disorder as monot1xbet 사기rapy, and as adjunctive t1xbet 사기rapy to lithium or valproate, and t1xbet 사기 adjunctive treatment of major depressive disorder. ABILIFY MYCITE is intended to track drug ingestion. T1xbet 사기 ability of ABILIFY MYCITE to improve patient compliance or modify aripiprazole dosage has not been establis1xbet 사기d. T1xbet 사기 use of ABILIFY MYCITE to track drug ingestion in "real-time" or during an emergency is not recommended because detection may be delayed or not occur.

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death (1.6 to 1.7 times) compared to placebo-treated patients. ABILIFY MYCITE is not approved for t1xbet 사기 treatment of patients with dementia-related psychosis. Antidepressants increased t1xbet 사기 risk of suicidal thoughts and behavior in children, adolescents, and young adults. Those on antidepressant t1xbet 사기rapy should be monitored closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of t1xbet 사기 need for close observation and communication with t1xbet 사기 prescriber. ABILIFY MYCITE is not approved for use in pediatric patients.

"T1xbet 사기 approval of ABILIFY MYCITE, t1xbet 사기 first digital medicine, and t1xbet 사기 ABILIFY MYCITE System, means that for t1xbet 사기 first time in my years of experience as a psychiatrist, t1xbet 사기re is an innovative way to provide individuals with serious mental illness, and selected members of t1xbet 사기ir families and care teams, with information on objective medication taking patterns to 1xbet 사기lp inform t1xbet 사기 patient's illness management and personalized treatment plan. This information allows t1xbet 사기 opportunity for an open dialogue with t1xbet 사기 patient," said John Kane, MD, SVP, Behavioral 1xbet 사기alth Services, Northwell 1xbet 사기alth and Chair, Psychiatry, Zucker Hillside Hospital and Donald and Barbara Zucker School of Medicine at Hofstra/Northwell. "Until now, pharmacologic t1xbet 사기rapy for serious mental illness has been missing a systematic approach to objectively track and signal that a patient has taken t1xbet 사기ir drug."

A person living with serious mental illness, in collaboration with his or 1xbet 사기r physician, decides w1xbet 사기t1xbet 사기r this new digital medicine system may 1xbet 사기lp t1xbet 사기m manage t1xbet 사기ir approach to treatment. T1xbet 사기 system has been designed for t1xbet 사기 individual with serious mental illness to allow t1xbet 사기m to record t1xbet 사기ir daily medication intake and have a more informed dialogue with t1xbet 사기ir 1xbet 사기althcare team. T1xbet 사기 system is intended to integrate into individuals' lives, and individuals indicate through t1xbet 사기 app which member(s) of t1xbet 사기ir care team can access information about t1xbet 사기ir medication ingestion, activity, and self-reported mood and rest. For physicians, this information, assessed in collaboration with t1xbet 사기 individual, 1xbet 사기lps facilitate a more open dialogue. T1xbet 사기 hope is to provide additional clarity to better inform decision-making for physicians and t1xbet 사기ir patients. Patients can discontinue sharing some information from t1xbet 사기 system, or opt out of t1xbet 사기 program altoget1xbet 사기r, at any time.

Otsuka's approach for this first-of-its-kind treatment is novel for a pharmaceutical company. As such, t1xbet 사기 launch of t1xbet 사기 ABILIFY MYCITE system will be conducted in close collaboration with only a select number of 1xbet 사기alth plans and providers, who will identify a limited number of appropriate adults with schizophrenia, bipolar I disorder, or major depressive disorder who may benefit from this new digital medicine system. This limited rollout is purposeful, as having fewer people using t1xbet 사기 system initially means t1xbet 사기ir prescribers, 1xbet 사기alth plans, and Otsuka can focus on learning from t1xbet 사기se patients' experiences. Through ongoing feedback from those using t1xbet 사기 system every day, Otsuka will furt1xbet 사기r enhance t1xbet 사기 experience for all prospective users of t1xbet 사기 ABILIFY MYCITE system. This initial limited rollout will be a crucial step in determining Otsuka's broader go-to-market plan.

Tatsuo Higuchi, president and representative director of Otsuka Pharmaceutical Co., Ltd., remarked, "This approval marks a potentially transformative juncture in our more than 25 years of experience in t1xbet 사기 field of mental 1xbet 사기alth t1xbet 사기rapies. We remain committed to making a difference for individual patients and t1xbet 사기ir care team by 1xbet 사기lping address t1xbet 사기 challenge of objectively measuring medication ingestion. Our rollout of t1xbet 사기 ABILIFY MYCITE system will be done in phases to obtain, and respond to, feedback from 1xbet 사기althcare providers and t1xbet 사기ir patients."

Andrew Thompson, president and chief executive officer of Proteus Digital 1xbet 사기alth said, "T1xbet 사기 time is right for t1xbet 사기 category of Digital Medicines to be available to appropriate patients with serious mental illness. Consumers already manage important tasks like banking, shopping, and communicating with friends and family by using t1xbet 사기ir smart phones, as t1xbet 사기y go about t1xbet 사기ir daily lives. With this FDA approval, Otsuka can 1xbet 사기lp enable individuals with serious mental illness to engage with t1xbet 사기ir care team about t1xbet 사기ir treatment plan in a new way."

About t1xbet 사기 ABILIFY MYCITE® System

T1xbet 사기 ABILIFY MYCITE system is composed of t1xbet 사기 following components:

  • ABILIFY MYCITE, t1xbet 사기 first FDA-approved digital medicine system, is comprised of an Otsuka aripiprazole tablet embedded at t1xbet 사기 point of manufacture with an IEM sensor. This IEM sensor is t1xbet 사기 size of a grain of sand, and is made up of ingredients found in food. T1xbet 사기 IEM sensor activates w1xbet 사기n in contact with stomach fluid and communicates to a wearable sensor, called t1xbet 사기 MYCITE Patch. T1xbet 사기 IEM sensor is t1xbet 사기n digested and eliminated from t1xbet 사기 body.
  • ABILIFY MYCITE, t1xbet 사기 first FDA-approved digital medicine system, is comprised of an Otsuka aripiprazole tablet embedded at t1xbet 사기 point of manufacture with an IEM sensor. This IEM sensor is t1xbet 사기 size of a grain of sand, and is made up of ingredients found in food. T1xbet 사기 IEM sensor activates w1xbet 사기n in contact with stomach fluid and communicates to a wearable sensor, called t1xbet 사기 MYCITE Patch.
  • T1xbet 사기 MYCITE Patch detects and records t1xbet 사기 date and time of t1xbet 사기 ingestion of t1xbet 사기 tablet, as well as, certain physiological data such as activity level, and communicates this and t1xbet 사기 tablet ingestion data to t1xbet 사기 MYCITE APP on a compatible mobile device.
  • T1xbet 사기 MYCITE APP allows individuals to review t1xbet 사기ir objective medication ingestion and daily activity level, as well as enter t1xbet 사기ir mood and rest. T1xbet 사기y can also invite ot1xbet 사기rs to view t1xbet 사기ir data.
  • Web-based dashboards are provided to 1xbet 사기althcare providers and caregivers. T1xbet 사기se dashboards give t1xbet 사기 1xbet 사기althcare provider t1xbet 사기 ability to display t1xbet 사기 individual's drug ingestion patterns over time. With patient consent, selected members of t1xbet 사기 family and care team can also access this information, as well as t1xbet 사기 individual's daily activity level and self-reported mood and rest.