Abilify MyCite (aripiprazole tablets embedded with sensor) / Otsuka - LARVOL DELTA

Developing a Sleep Algxorithm to Support a Digital Medicine System: Noninterventional, Observational Sleep Study. (PubMed, JMIR Ment Health) - "The RW2 patch is part of a digital medicine system (aripiprazole with sensor) designed to provide objective records of medication ingestion for patients with schizophrenia, bipolar I disorder, and major depressive disorder. Using industry-best practices, we developed a sleep algorithm for use with the RW2 patch that can accurately detect sleep and wake windows compared to PSG-labeled sleep data. This algorithm may be used for a more complete understanding of well-being for patients with SMI in a real-world setting, without the need for PSG and a sleep lab."

Journal • Observational data • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • Schizophrenia • Sleep Disorder

The First Smart Pill: Digital Revolution or Last Gasp? (PubMed, Kennedy Inst Ethics J) - "This history illuminates how an antipsychotic can become a top-selling drug and maintain its blockbuster status for more than a decade. It also provides a detailed case study for how knowledge is constructed within the logic of biomedical capitalism, providing impetus to reexamine claims regarding how MyCite addresses patient nonadherence, engenders patient support, and is ethicist-approved."

Journal • CNS Disorders

A Trial to Assess a Wearable Patch's Functioning to Detect Medication Ingestion (clinicaltrials.gov) - P=N/A | N=54 | Completed | Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

New trial • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mental Retardation • Mood Disorders • Psychiatry • Schizophrenia

Safety Evaluation in Iterative Development of Wearable Patches for Aripiprazole Tablets With Sensor: Pooled Analysis of Clinical Trials. (PubMed, JMIR Form Res) - P2, P3, P4 | "The incidence rates of SIEs reported as the wearable patch versions evolved from RP4 through RW2 suggest that information derived from reported adverse events may have informed product design and development, which could have improved both tolerability and wearability of successive products."

Journal • Retrospective data • Bipolar Disorder • CNS Disorders • Depression • Dermatitis • Dermatology • Immunology • Major Depressive Disorder • Mood Disorders • Pain • Pruritus • Psychiatry • Schizophrenia

Real-World Evidence of Aripiprazole Tablets with Sensor: Treatment Patterns and Impacts on Psychiatric Healthcare Resource Utilization. (PubMed, Clinicoecon Outcomes Res) - "Aripiprazole tablets with sensor (AS) contain an ingestible event marker and communicate with wearable patches and a smartphone app to provide objective medication ingestion data...These preliminary results suggest AS usage can help build regular medication-taking habits and holds promise for reducing psychiatric HCRU. Additional studies with larger sample sizes are warranted to inform clinical practice and coverage decisions."

HEOR • Journal • Real-world • Real-world evidence • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • Schizophrenia

Cost-Effectiveness of Aripiprazole Tablets with Sensor versus Oral Atypical Antipsychotics for the Treatment of Schizophrenia Using a Patient-Level Microsimulation Modeling Approach. (PubMed, Clinicoecon Outcomes Res) - "The results from the sensitivity analyses were consistent with those of the base case analysis. AS may be a cost-effective strategy, with lower costs and improved quality of life among patients with schizophrenia over 12 months, from the payer and societal perspectives."

Cost effectiveness • HEOR • Journal • CNS Disorders • Psychiatry • Schizophrenia

A Comparison of Oral Aripiprazole with an Ingestible Sensor with Oral Atypical Antipsychotic Treatment and Impact on Psychiatric Hospitalizations in Adults with Schizophrenia in a Real-World Care Setting (ISPOR 2023) - "The results of this analysis are consistent with findings from the AS trial; it might suggest that treatment with AS for adults with schizophrenia indicates a reduction in psychiatric hospitalization."

Clinical • Real-world • Real-world evidence • CNS Disorders • Psychiatry • Schizophrenia

A Comparison of Oral Aripiprazole with an Ingestible Sensor with Oral Atypical Antipsychotic Treatment and Impact on Psychiatric Hospitalizations in Adults with Schizophrenia in a Real-World Care Setting (ASCP 2023) - "The results of this analysis are consistent with findings from the AS trial; it might suggest that treatment with AS for adults with schizophrenia indicates a reduction in psychiatric hospitalization. Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. Learning Objectives 1."

Clinical • Real-world • Real-world evidence • CNS Disorders • Psychiatry • Schizophrenia

Digital Medicine System in Veterans With Severe Mental Illness: Feasibility and Acceptability Study. (PubMed, JMIR Form Res) - P4 | "There was no observed difference in refill rates. Among those who engaged in the DMS arm, the proportion of days covered by refills were relatively high (mean 0.85, SD 0.20). The qualitative analyses highlighted areas for further refinement of the DMS."

Journal • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • Schizophrenia

Use of an Ingestible, Sensor-Based Digital Adherence System to Strengthen the Therapeutic Relationship in Serious Mental Illness. (PubMed, JMIR Ment Health) - "The system records ingestions through an embedded ingestible sensor in oral aripiprazole, which sends a transient local signal to a patch worn on the patient's torso that is then stored on a paired smartphone app. Future investigations are needed to examine how this technology impacts the development of training and best practice guidelines for its use. Otherwise, the potential benefits of this technology may be lost, or worse, inadequate and inappropriate use may harm the therapeutic relationship."

Journal • CNS Disorders

Healthcare Provider Engagement with a Novel Dashboard for Tracking Medication Ingestion: Impact on Treatment Decisions and Clinical Assessments for Adults with Schizophrenia. (PubMed, Neuropsychiatr Dis Treat) - "A phase 3b open-label clinical trial used aripiprazole tablets with sensor (AS; includes pills with ingestible event-marker, wearable sensor patches and smartphone application) in adults with schizophrenia...Most HCPs found the dashboard easy to use (74%) and helpful for improving conversations with participants about their treatment plan and progress (78%). This provider dashboard may facilitate discussions with patients about regular medication-taking, which can improve patient outcomes."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Participant Engagement and Symptom Improvement: Aripiprazole Tablets with Sensor for the Treatment of Schizophrenia. (PubMed, Patient Prefer Adherence) - P3 | "A recent, phase 3b, mirror-image clinical trial of outpatients with schizophrenia found that use of aripiprazole tablets with sensor (AS; Abilify MyCite, comprising an ingestible event-marker sensor embedded in aripiprazole tablets, wearable sensor patches, and a smartphone application) reduced the incidence of psychiatric hospitalizations relative to oral standard-of-care antipsychotics...Participants who completed 3 months of the study and had higher AS engagement experienced significantly greater improvement in their end-of-study clinical assessments versus participants who did not complete 3 months. Improvement may be related to more-consistent medication intake and better engagement with a digital health system."

Journal • CNS Disorders • Psychiatry • Schizophrenia

A Real-World (RW) Comparison of Healthcare Expenditures in Patients Prescribed Aripiprazole Tablet with Sensor (AS) and Patients Prescribed Aripiprazole Alone [Aripiprazole without Sensor (ARI)] in the US (ISPOR 2022) - "OBJECTIVES: Indicated for treatment of adults with bipolar I disorder (BP1), schizophrenia (SCZ) and major depressive disorder (MDD), AS is a drug-device system comprised of aripiprazole tablets embedded with an Ingestible Event Marker tracking drug ingestion, mood, rest and physical activity. This study provides RW evidence showing that AS may have clinical benefit resulting in decreased psychiatric medical charges. Increased all-cause medical charges in AS patients may be an indication of increased monitoring/awareness in these patients. Additional studies with larger samples and longer follow-up are warranted."

Clinical • Real-world evidence • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • Schizophrenia

Early Experience with Aripiprazole Tablets with Sensor: Patient Costs from Real-World Data (ISPOR 2022) - "Conclusion These results suggest that individuals who use AS experienced a decrease in the psychiatric acute care costs and increased outpatient service costs. Future research should focus on an expanded population of users with longer baseline and follow-up measurements to confirm these results."

Clinical • Real-world evidence • CNS Disorders • Psychiatry

Utility and Usability of Aripiprazole Tablets with Sensor: Aggregated Survey Data from 3 Clinical Trials of Participants with Serious Mental Illness - P2, P3 | "Introduction With the advent of new digital technologies to treat mental health disorders, usability and utility of these tools for patients with serious mental illness becomes an important concern.1 Aripiprazole tablets with sensor (AS, Abilify MyCite®, comprising an ingestible event-marker sensor embedded in aripiprazole tablets, wearable sensor patches, and a smartphone application) is a digital medicine approved for the treatment of schizophrenia and bipolar 1 disorder, and as adjunctive treatment for major depressive disorder.2 In this analysis, previously collected survey data on the utility and usability of the AS system for participants and healthcare providers (HCPs) were evaluated across 3 clinical trials of participants with schizophrenia, bipolar I disorder, or major depressive disorder...Across the 3 studies, both participants and HCPs responded positively to AS and found the system usable, and participants were satisfied with the system in..."

Clinical • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • Schizophrenia

A Real-World Comparison of Patients Prescribed Aripiprazole Tablet with Sensor and Patients Prescribed Aripiprazole Alone in the US - "Background: Aripiprazole tablet with sensor (AS) is a drug-device system comprised of aripiprazole tablets embedded with an Ingestible Event Marker sensor to track drug ingestion, mood, rest and physical activity, and is indicated for the treatment of adults with bipolar I disorder (BP I), schizophrenia (SCZ), and major depressive disorder (MDD)... Results from this preliminary real-world comparative analysis suggest that AS may have clinical benefit resulting in a decrease in inpatient/ED visits and psychiatric medical charges. The study is limited to patients with a prescription and shipment of AS and matched controls, however actual use is not confirmed. Future analyses conducted among a larger sample, longer follow-up, and confirmed users of AS matched to non-users allowing for analysis separately for BP I, MDD and SCZ are warranted."

Clinical • Real-world evidence • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mental Retardation • Mood Disorders • Psychiatry • Schizophrenia

Evaluation of Aggregated Safety Data Across Clinical Trials of Iteratively Developed Wearable Sensor Patches for Digital Medicine (APA 2022) - "In this study, we investigated aggregate safety data for the sensor patch component of aripiprazole tablets with sensor (AS [Abilify MyCite ® ]; includes aripiprazole tablets with an embedded ingestible event-marker sensor, wearable sensor patches, and a smartphone application)... In the development of wearable sensors, biocompatibility considerations are a priority. 3 Our iteratively developed sensor patch component of the AS highlights how feedback from clinical trial participants regarding comfort, ease of wear, and reported adverse events can be incorporated into product design to develop safer, more wearable successive products."

Clinical • CNS Disorders • Dermatitis • Dermatology • Immunology • Pain • Pruritus • Psychiatry

Phase 3b Multicenter, Prospective, Open-label Trial to Evaluate the Effects of a Digital Medicine System on Inpatient Psychiatric Hospitalization Rates for Adults With Schizophrenia. (PubMed, J Clin Psychiatry) - P3 | "The AS system may aid medication ingestion and is associated with improvements in symptoms, potentially reducing acute-care needs among patients with schizophrenia. Trial Registration: ClinicalTrials.gov identifier: NCT03892889."

Journal • P3 data • CNS Disorders • Psychiatry • Schizophrenia

A Trial in Adult Participants With Schizophrenia Treated Prospectively for 6-months With Abilify MyCite® (clinicaltrials.gov) - P3; N=277; Terminated; Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.; Trial completion date: Feb 2021 ➔ Sep 2020; Recruiting ➔ Terminated; Study has stopped for having met the primary endpoint.

Clinical • Trial completion date • Trial termination • CNS Disorders • Psychiatry • Schizophrenia

Ministry of Food and Drug Safety approved 26 clinical trials last week ... 3 cases of phase 3, 7 cases of viability [Google translation] (Health Korea News) - "The Ministry of Food and Drug Safety has approved a total of 26 clinical trials over the past week (2nd to 6th)....The Ministry of Food and Drug Safety also approved seven bioequivalence tests for the release of generic drugs....Myungin Pharmaceutical received approval for a bioactivity test comparing its 'Repisol Tablet' (Aripiprazole) and Korea Otsuka Pharmaceutical's 'Abilify Tablet' (Aripiprazole)."

New trial • CNS Disorders • Schizophrenia

[VIRTUAL] Inpatient Psychiatric Hospitalization Rates in Adults With Schizophrenia: A Phase 3b Open-Label Study of a Digital Medicine System (APA 2021) - "Ensuring medication adherence is a major challenge in patients with schizophrenia.1 The digital medicine system (DMS), comprised of aripiprazole tablets embedded with an ingestible event-marker sensor, wearable sensor patches, and a smartphone application, is indicated for the treatment of adults with schizophrenia or bipolar disorder I (with or without lithium or valproate), and as adjunct treatment for adults with major depressive disorder.2 Patients can track their treatment ingestion data via a smartphone application, while investigators, clinicians, and caregivers can track these data using separate Web-based dashboards...We conclude that, compared with oral SOC therapy, the DMS may reduce inpatient psychiatric hospitalization rates among adults with schizophrenia. By giving providers objective ingestion data to inform timely and appropriate treatment decisions, the DMS may reduce healthcare utilization among patients with schizophrenia."

Clinical • P3 data • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • Schizophrenia • Suicidal Ideation

[VIRTUAL] A Phase 3b Multi-Center, Prospective, Open-Label Trial to Evaluate the Effects of a Digital Medicine System on Inpatient Psychiatric Hospitalization Rates in Adults with Schizophrenia (ASCP 2021) - "The digital medicine system (DMS), comprised of aripiprazole tablets embedded with an ingestible event-marker sensor, wearable sensor skin patches, and a smartphone application, is indicated for the treatment of adults with schizophrenia, bipolar disorder I (with or without lithium or valproate), or as adjunct treatment for adults with major depressive disorder.1 Patients can track their treatment ingestion data via a smartphone application, while investigators, clinicians, and caregivers can track these data using separate Web-based dashboards...2. Understand the role of the DMS in informing treatment decisions."

Clinical • P3 data • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • Schizophrenia • Suicidal Ideation

[fist! e-Technology] ’Digital Therapy’ opens a new way to treat chronic diseases [Google translation] (eDaily) - "According to the Korea Institute of Industrial Technology Evaluation and Management, digital therapy refers to an advanced software medical device that provides evidence-based therapeutic interventions to patients to prevent, manage, and further treat diseases....Currently FDA-approved digital treatments include Teva, ProAir Digihaler (asthma), WellDoc, BlueStar (type 2 diabetes), Voluntis, Insulia (type 2 diabetes) and Oleena (cancer), Proteus Digital Health (Proteus Digital Health) Abilify Mycite (schizophrenia)."

Review • Asthma • CNS Disorders • Depression • Schizophrenia

Hummingbird Study: Results from an Exploratory Trial Assessing the Performance and Acceptance of a Digital Medicine System in Adults with Schizophrenia, Schizoaffective Disorder, or First-Episode Psychosis. (PubMed, Neuropsychiatr Dis Treat) - P4 | "Eligible adults were diagnosed with schizophrenia, schizoaffective disorder, or first-episode psychosis; were receiving aripiprazole, quetiapine, olanzapine, or risperidone; and could use the DMS with the application downloaded on a personal smartphone. Medical device skin irritations were the only TEAEs reported. The DMS had sufficient performance in, and acceptance from, subjects with psychotic disorders and was generally well tolerated."

Clinical • CNS Disorders • Psychiatry • Schizophrenia

Abilify MyCite (Aripiprazole): A Critical Evaluation of the Novel Dosage Form. (PubMed, J Clin Psychopharmacol) - No abstract available

Journal