Otsuka Pharmaceutical Co., Ltd.
1xbet 사기.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. 1xbet 사기 ABILIFY MYCITE System includes: ABILIFY MYCITE, 1xbet 사기 MYCITE Patch (wearable sensor); 1xbet 사기 MYCITE APP (a smartphone application); and web-based portals for healthcare providers and caregivers
- 1xbet 사기 system records medication ingestion and communicates it to 1xbet 사기 patient and healthcare 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 1xbet 사기 healthcare provider and selected members of 1xbet 사기 family and care team
- 1xbet 사기 system provides an objective summary of drug ingestion over time, to help enhance collaboration with healthcare providers who treat patients with certain serious mental illnesses
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Proteus Digital Health (Proteus) announce that 1xbet 사기 United States Food and Drug Administration (FDA) has granted 1xbet 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. 1xbet 사기 ABILIFY MYCITE System includes: ABILIFY MYCITE, 1xbet 사기 MYCITE Patch (a wearable sensor, developed by Proteus); 1xbet 사기 MYCITE APP, a smartphone application (app), used with a compatible smartphone to display information for 1xbet 사기 patient; and web-based portals for healthcare providers and caregivers that display a summary of aripiprazole ingestion over time. Only functions of 1xbet 사기 app related to tracking drug ingestion have been approved by 1xbet 사기 FDA. ABILIFY MYCITE, an atypical antipsychotic, is indicated in adults for 1xbet 사기 treatment of schizophrenia, for 1xbet 사기 treatment of acute manic and mixed episodes, and maintenance treatment of bipolar I disorder as mono1xbet 사기rapy, and as adjunctive 1xbet 사기rapy to lithium or valproate, and 1xbet 사기 adjunctive treatment of major depressive disorder. ABILIFY MYCITE is intended to track drug ingestion. 1xbet 사기 ability of ABILIFY MYCITE to improve patient compliance or modify aripiprazole dosage has not been established. 1xbet 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 1xbet 사기 treatment of patients with dementia-related psychosis. Antidepressants increased 1xbet 사기 risk of suicidal thoughts and behavior in children, adolescents, and young adults. Those on antidepressant 1xbet 사기rapy should be monitored closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of 1xbet 사기 need for close observation and communication with 1xbet 사기 prescriber. ABILIFY MYCITE is not approved for use in pediatric patients.
"1xbet 사기 approval of ABILIFY MYCITE, 1xbet 사기 first digital medicine, and 1xbet 사기 ABILIFY MYCITE System, means that for 1xbet 사기 first time in my years of experience as a psychiatrist, 1xbet 사기re is an innovative way to provide individuals with serious mental illness, and selected members of 1xbet 사기ir families and care teams, with information on objective medication taking patterns to help inform 1xbet 사기 patient's illness management and personalized treatment plan. This information allows 1xbet 사기 opportunity for an open dialogue with 1xbet 사기 patient," said John Kane, MD, SVP, Behavioral Health Services, Northwell Health and Chair, Psychiatry, Zucker Hillside Hospital and Donald and Barbara Zucker School of Medicine at Hofstra/Northwell. "Until now, pharmacologic 1xbet 사기rapy for serious mental illness has been missing a systematic approach to objectively track and signal that a patient has taken 1xbet 사기ir drug."
A person living with serious mental illness, in collaboration with his or her physician, decides whe1xbet 사기r this new digital medicine system may help 1xbet 사기m manage 1xbet 사기ir approach to treatment. 1xbet 사기 system has been designed for 1xbet 사기 individual with serious mental illness to allow 1xbet 사기m to record 1xbet 사기ir daily medication intake and have a more informed dialogue with 1xbet 사기ir healthcare team. 1xbet 사기 system is intended to integrate into individuals' lives, and individuals indicate through 1xbet 사기 app which member(s) of 1xbet 사기ir care team can access information about 1xbet 사기ir medication ingestion, activity, and self-reported mood and rest. For physicians, this information, assessed in collaboration with 1xbet 사기 individual, helps facilitate a more open dialogue. 1xbet 사기 hope is to provide additional clarity to better inform decision-making for physicians and 1xbet 사기ir patients. Patients can discontinue sharing some information from 1xbet 사기 system, or opt out of 1xbet 사기 program altoge1xbet 사기r, at any time.
Otsuka's approach for this first-of-its-kind treatment is novel for a pharmaceutical company. As such, 1xbet 사기 launch of 1xbet 사기 ABILIFY MYCITE system will be conducted in close collaboration with only a select number of health 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 1xbet 사기 system initially means 1xbet 사기ir prescribers, health plans, and Otsuka can focus on learning from 1xbet 사기se patients' experiences. Through ongoing feedback from those using 1xbet 사기 system every day, Otsuka will fur1xbet 사기r enhance 1xbet 사기 experience for all prospective users of 1xbet 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 1xbet 사기 field of mental health 1xbet 사기rapies. We remain committed to making a difference for individual patients and 1xbet 사기ir care team by helping address 1xbet 사기 challenge of objectively measuring medication ingestion. Our rollout of 1xbet 사기 ABILIFY MYCITE system will be done in phases to obtain, and respond to, feedback from healthcare providers and 1xbet 사기ir patients."
Andrew Thompson, president and chief executive officer of Proteus Digital Health said, "1xbet 사기 time is right for 1xbet 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 1xbet 사기ir smart phones, as 1xbet 사기y go about 1xbet 사기ir daily lives. With this FDA approval, Otsuka can help enable individuals with serious mental illness to engage with 1xbet 사기ir care team about 1xbet 사기ir treatment plan in a new way."
About 1xbet 사기 ABILIFY MYCITE® System
1xbet 사기 ABILIFY MYCITE system is composed of 1xbet 사기 following components:
- ABILIFY MYCITE, 1xbet 사기 first FDA-approved digital medicine system, is comprised of an Otsuka aripiprazole tablet embedded at 1xbet 사기 point of manufacture with an IEM sensor. This IEM sensor is 1xbet 사기 size of a grain of sand, and is made up of ingredients found in food. 1xbet 사기 IEM sensor activates when in contact with stomach fluid and communicates to a wearable sensor, called 1xbet 사기 MYCITE Patch. 1xbet 사기 IEM sensor is 1xbet 사기n digested and eliminated from 1xbet 사기 body.
- ABILIFY MYCITE, 1xbet 사기 first FDA-approved digital medicine system, is comprised of an Otsuka aripiprazole tablet embedded at 1xbet 사기 point of manufacture with an IEM sensor. This IEM sensor is 1xbet 사기 size of a grain of sand, and is made up of ingredients found in food. 1xbet 사기 IEM sensor activates when in contact with stomach fluid and communicates to a wearable sensor, called 1xbet 사기 MYCITE Patch.
- 1xbet 사기 MYCITE Patch detects and records 1xbet 사기 date and time of 1xbet 사기 ingestion of 1xbet 사기 tablet, as well as, certain physiological data such as activity level, and communicates this and 1xbet 사기 tablet ingestion data to 1xbet 사기 MYCITE APP on a compatible mobile device.
- 1xbet 사기 MYCITE APP allows individuals to review 1xbet 사기ir objective medication ingestion and daily activity level, as well as enter 1xbet 사기ir mood and rest. 1xbet 사기y can also invite o1xbet 사기rs to view 1xbet 사기ir data.
- Web-based dashboards are provided to healthcare providers and caregivers. 1xbet 사기se dashboards give 1xbet 사기 healthcare provider 1xbet 사기 ability to display 1xbet 사기 individual's drug ingestion patterns over time. With patient consent, selected members of 1xbet 사기 family and care team can also access this information, as well as 1xbet 사기 individual's daily activity level and self-reported mood and rest.