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Otsuka Pharmaceutical Gets FDA Approval for First Sensor-Embedded Drug

Oral Abilify tablet embedded with ingestible event marker sensor.

While Richard Fleischer’s vision of our medical future in Fantastic Voyage may still be in the realm of science fiction, Otsuka Pharmaceuticals and Proteus Digital Health have advanced medical technology another step forward in science fact. Yesterday the FDA approved the first drug in the US that comes with digital ingestion tracking. The “digital medicine system,” as Otsuka Pharmaceuticals (subsidiary of Japanese pharmaceutical giant Otsuka Holdings, OTC – OTSKY) refers to it, is comprised of Otsuka’s oral Abilify (aripiprazole) tablet embedded with an ingestible event marker (IEM) sensor that’s the size of a grain of sand, wearable sensor patch, a smartphone application and a web-based portal for healthcare providers and caregivers that displays a summary of ingestion over time. The sensor and associated technology were developed by Proteus. The new digital system is known as Abilify MyCite.

Being able to track ingestion of medications prescribed for mental illness may be useful for some patients. 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.

– Mitchell Mathis, MD, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research

Otsuka has marketed Abilify since 2002 for schizophrenia. The medication is used today to also treat manic or mixed episodes associated with bipolar I disorder, major depressive disorder (when used with antidepressants), irritability associated with autism and Tourette’s disorder. According to STAT, Otsuka “had lost market share after Abilify went generic but will now have a way to make the product stand out. The company is expected to price the new product at a markup above the original Abilify. The company is finalizing that price and expects to announce it next year, closer to the product launch, according to company spokeswoman Kimberly Whitefield.”

Proteus Digital Health has more than 440 issued patents around the sensor technology and regulatory clearances in the US, European Union and China. The company is privately held by investors including Carlyle, Essex Woodlands, Kaiser Permanente, Medtronic, Novartis, Oracle, ON Semiconductor and Otsuka.

According to The New York Times, “experts estimate that so-called nonadherence or noncompliance to medication costs about $100 billion a year, much of it because patients get sicker and need additional treatment or hospitalization.”

When patients don’t adhere to lifestyle or medications that are prescribed for them, there are really substantive consequences that are bad for the patient and very costly.

– Dr. William Shrank, chief medical officer of the health plan division at the University of Pittsburgh Medical Center.

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