U.S. Food and Drug Administration

The U.S. Food and Drug Administration today approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults.
The system works by sending a message from the pill’s sensor to a wearable patch. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone. Patients can also permit their caregivers and physician to access the information through a web-based portal.

3 thoughts on “U.S. Food and Drug Administration

  1. shinichi Post author

    FDA approves pill with sensor that digitally tracks if patients have ingested their medication

    New tool for patients taking Abilify

    FDA News Release

    U.S. Food and Drug Administration

    November 13, 2017

    https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584933.htm

    The U.S. Food and Drug Administration today approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults.
    The system works by sending a message from the pill’s sensor to a wearable patch. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone. Patients can also permit their caregivers and physician to access the information through a web-based portal.

    “Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”

    It is important to note that Abilify MyCite’s prescribing information (labeling) notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown. Abilify MyCite should not be used to track drug ingestion in “real-time” or during an emergency because detection may be delayed or may not occur.

    Schizophrenia is a chronic, severe and disabling brain disorder. About 1 percent of Americans have this illness. Typically, symptoms are first seen in adults younger than 30 years of age. Symptoms of those with schizophrenia include hearing voices, believing other people are reading their minds or controlling their thoughts, and being suspicious or withdrawn. Bipolar disorder, also known as manic-depressive illness, is another brain disorder that causes unusual shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks. The symptoms of bipolar disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior and a decreased need for sleep.

    Abilify MyCite contains a Boxed Warning alerting health care professionals that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Abilify MyCite is not approved to treat patients with dementia-related psychosis. The Boxed Warning also warns about an increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants. The safety and effectiveness of Abilify MyCite have not been established in pediatric patients. Patients should be monitored for worsening and emergence of suicidal thoughts and behaviors. Abilify MyCite must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.

    In the clinical trials for Abilify, the most common side effects reported by adults taking Abilify were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness. Skin irritation at the site of the MyCite patch placement may occur in some patients.

    Prior to initial patient use of the product, the patient’s health care professional should facilitate use of the drug, patch and app to ensure the patient is capable and willing to use the system.

    Abilify was first approved by the FDA in 2002 to treat schizophrenia. The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012.

    The FDA granted the approval of Abilify MyCite to Otsuka Pharmaceutical Co., Ltd. The sensor technology and patch are made by Proteus Digital Health.

    The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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  2. shinichi Post author

    Abilify MyCite Approval History

    Drugs.com

    https://www.drugs.com/history/abilify-mycite.html

    • FDA approved: Yes (First approved November 13th, 2017)
    • Brand name: Abilify MyCite
    • Generic name: aripiprazole
    • Company: Otsuka Pharmaceutical Co., Ltd
    • Treatment for: Schizophrenia, Bipolar Disorder, Depression, Major Depressive Disorder

    Abilify MyCite (aripiprazole) is a tablet formulation of an approved atypical antipsychotic embedded with an ingestible Proteus® sensor that communicates with a wearable sensor patch and a medical software application to measure adherence in the treatment of adults with schizophrenia, bipolar I disorder, and major depressive disorder.

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  3. shinichi Post author

    センサー内蔵の錠剤「デジタルメディスン」が登場

    大塚製薬などがFDA申請、服薬をスマホで管理

    by 大下 淳一

    http://techon.nikkeibp.co.jp/atcl/news/15/091400312/?ST=health

     シリコン製のセンサーチップを内蔵した錠剤の新薬承認申請(NDA)を、米国FDAが2015年9月8日に受理した。大塚製薬の抗精神病薬「エビリファイ錠」に、米Proteus Digital Health社のセンサーを内蔵したものだ。医薬品と医療機器(センサー)を一体化した製品の審査は、FDAにとって初。2015年9月11日に両社が申請受理を発表した(プレスリリース)。

     デジタルメディスンは、エビリファイの錠剤に、Proteus社が開発した“飲み込めるセンサーチップ”を内蔵したもの(関連記事)。エビリファイ錠の適応として承認されている、成人の統合失調症や双極性Ⅰ型障害の躁病、混合型症状の急性期、大うつ病性障害の補助療法に使う。目的は服薬アドヒアランスの測定と向上だ。

    服薬情報や活動パターンを記録

     この薬を服用して胃に到達すると、患者の体に貼り付けたパッチ型検出器に対し、内蔵したセンサーが信号を送る。このパッチはセンサーから送られる服薬時刻などの情報に加え、体の傾きや活動量などの身体情報を集め、時間と併せて記録する。収集したデータはスマートフォンやタブレット端末にBluetoothで転送され、患者の同意のもとで医師や看護師が参照可能だ。この情報を基に患者に適した治療法を選定でき、結果として服薬アドヒアランスを向上させられるという。

     精神疾患の患者は長期にわたる服薬が必要だが、薬を飲まなくなったり飲み忘れたりするなど、規則正しく服薬できない状態に陥りがち。薬を定期的に飲まなくなると再発リスクが増大する。今回の薬剤では「患者の服薬状況や身体状態を正確に把握でき、薬効がより確実に発揮される。個人の服薬パターンやライフスタイル、日頃の活動を知ることで、個々人に最適な薬の処方が行えるようになる」(Proteus Digital Health社President&CEOのAndrew Thompson氏)。

     Proteus社は、飲み込めるセンサーと貼付パッチについて、FDAから医療機器の認証を取得済み。欧州連合(EU)では医療機器指令(MDD)に基づくCEマークを取得している。Proteus社のセンサーはエビリファイ製造時に埋め込まれ、パッチおよび関連医療ソフトウエアと通信する医薬品・医療機器製品として扱われる。

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