FDA Approves Pill With Sensor Abilify MyCite; Otsuka Stock Up

FDA approves first drug in US with digital ingestion tracking

The Japanese drug maker Otsuka Pharmaceutical won the approval for an upgraded version of Abilify, the antipsychotic drug first approved 15 years ago to treat schizophrenia, bipolar disorder, and depression. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible sensor embedded in the pill that records that the medication was taken.

Abilify on its own had received FDA's approval in 2002 for the treatment of schizophrenia. Otsuka collaborated with Proteus Digital Health, the Silicon Valley company that designed the futuristic sensor technology. A resubmission of the new drug application was accepted by the agency in May 2017.

Mitchell Mathis, director of the Division of Psychiatry Products in the FDA'sCenter for Drug Evaluation and Research, said, "Being able to track ingestion of medications prescribed for mental illness may be useful for some patients". Data from the tracker can be kept private for the patient alone to see, with the option to share data with healthcare professionals or other individuals, if desired.

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Caregivers and physicians can also be permitted by the patients to get the information via a web-based portal.

The drug regulator warns that Abilify MyCite should not be used for real-time tracking of drug ingestion or during an emergency as detection could be delayed or may not take place. Estimates suggest that 50% of patients with chronic conditions do not take their medications, costing the United States healthcare system upwards of $100 billion in avoidable costs. Among them, the FDA said it was important to note that Abilify MyCite's labeling asserts "the ability of the product to improve patient compliance with their treatment regimen has not been shown". The Boxed Warning also warns that if children, adolescents and young adults mix antidepressants and Abilify MyCite, it will increase their risk of suicidal thinking and behavior.

In clinical trials establishing the efficacy of aripiprazole, the most common adverse events 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 also occur.

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