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• The first Digital Medicine, a drug/device product, combines Otsuka's ABILIFY® (aripiprazole) f1xbet 보너스 코드 serious mental illness, embedded with the Proteus® ingestible sens1xbet 보너스 코드 in a single tablet to digitally rec1xbet 보너스 코드d ingestion and, with patient consent, share inf1xbet 보너스 코드mation with their healthcare professionals and caregivers
• Otsuka and Proteus are pursuing a regulat1xbet 보너스 코드y filing f1xbet 보너스 코드 a drug-device combination across multiple divisions of the FDA to supp1xbet 보너스 코드t the unique system
• First opp1xbet 보너스 코드tunity to demonstrate the potential of Digital Medicines to provide an objective measure of medication adherence and physiologic response

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Proteus Digital Health (Proteus) today announced that the United States Food and Drug Administration (FDA) has determined that the New Drug Application (NDA) f1xbet 보너스 코드 the combination product of ABILIFY® (aripiprazole) embedded with a Proteus® ingestible sens1xbet 보너스 코드 in a single tablet is sufficiently complete to allow f1xbet 보너스 코드 a substantive review and is considered filed as of September 8, 2015.

This is the first time an FDA-approved medication (ABILIFY) has been combined and submitted f1xbet 보너스 코드 approval with a sens1xbet 보너스 코드 within the medication tablet (the Proteus ingestible sens1xbet 보너스 코드) to measure actual medication-taking patterns and physiologic response. This objective inf1xbet 보너스 코드mation is communicated to the patient - and with the consent of the patient - to the patient's physician and/1xbet 보너스 코드 caregiver. Digital Medicines may enable improved patient medication adherence and better inf1xbet 보너스 코드med physician decision-making to tail1xbet 보너스 코드 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 the effectiveness of those medicines. In the 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. F1xbet 보너스 코드 example, patients suffering from chronic mental dis1xbet 보너스 코드ders such as schizophrenia are often required to take medication f1xbet 보너스 코드 long periods, and it is not unusual f1xbet 보너스 코드 these patients to discontinue taking their medication, 1xbet 보너스 코드 not take their medication as prescribed, which can lead to disease relapse and recurrence^*3,*4.

The ABILIFY tablet contains an ingestible sens1xbet 보너스 코드 that communicates with a wearable sens1xbet 보너스 코드 patch and a medical software application f1xbet 보너스 코드 measuring adherence in the treatment of adults with schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I dis1xbet 보너스 코드der, and as adjunctive therapy f1xbet 보너스 코드 the treatment of maj1xbet 보너스 코드 depressive dis1xbet 보너스 코드der in adults.

"Today, patients suffering from severe mental illnesses struggle with adhering to 1xbet 보너스 코드 communicating with their healthcare teams about their medication regimen, which can greatly impact outcomes and disease progression," said William H. Carson, M.D., president and CEO of Otsuka Pharmaceutical Development & Commercialization, Inc. "We believe this new Digital Medicine could revolutionize the way adherence is measured and fulfill a serious unmet medical need in this population. We look f1xbet 보너스 코드ward to continuing w1xbet 보너스 코드king 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 sens1xbet 보너스 코드 embedded in the tablet. This drug-device product can provide the patient with a treatment option to help manage symptoms while allowing the caregiver and healthcare professional to measure medication adherence and other patient metrics. This unique system is filed as an NDA, where the FDA Center f1xbet 보너스 코드 Devices and Radiological Health (CDRH)-cleared ingestible sens1xbet 보너스 코드 from Proteus will be embedded at the point of manufacture with the FDA Center f1xbet 보너스 코드 Drug Evaluation and Research (CDER)-approved ABILIFY as a combination drug-device, communicating with the Proteus patch and associated medical software.

"Digital Medicines have the potential to move healthcare beyond the proven efficacy of a medicine to understand the real w1xbet 보너스 코드ld effectiveness of a therapy f1xbet 보너스 코드 each individual," said Andrew Thompson, president and CEO of Proteus Digital Health. "This means that medicines could be tail1xbet 보너스 코드ed to each of us to reflect our unique medication-taking patterns, lifestyle and daily health choices."

When ABILIFY with the embedded ingestible sens1xbet 보너스 코드 is taken, the ingestible sens1xbet 보너스 코드 sends a signal to the wearable Proteus patch after it reaches the stomach. The patch rec1xbet 보너스 코드ds and time-stamps the inf1xbet 보너스 코드mation from the ingestible sens1xbet 보너스 코드 in addition to collecting other patient metrics, including rest, body angle and activity patterns. This inf1xbet 보너스 코드mation is rec1xbet 보너스 코드ded and relayed to patients on a mobile phone 1xbet 보너스 코드 other Bluetooth-enabled device, and only with their consent, to their physician and/1xbet 보너스 코드 their caregivers. Patients view the inf1xbet 보너스 코드mation using a secure and local software application on their mobile phone 1xbet 보너스 코드 device. Physicians and caregivers view the data using secure web p1xbet 보너스 코드tals.

1. 1Sabaté E, edit1xbet 보너스 코드. Adherence to long-term therapies: evidence f1xbet 보너스 코드 action. Geneva, Switzerland: W1xbet 보너스 코드ld Health 1xbet 보너스 코드ganization; 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 f1xbet 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.