Published: Tue, November 14, 2017
Research | By Raquel Erickson

FDA Approves Digital Pill

FDA Approves Digital Pill

The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone. By allowing physicians to track a patient's use, Nath said he hopes to avert "dramatic and immediate health-care crises, such as for schizophrenia patients where missing medicines can result in a psychotic break which will land them in an ER".

According to the FDA, the Abilify has been approved for the treatment of schizophrenia and bipolar disorder, as well as an add-on treatment for depression.

Since digital Abilify hasn't been shown to improve patient compliance, it should not be used to track drug ingestion in real-time or during an emergency, the FDA said.

Always forget if you've taken your medication?

The Centers for Disease Control and Prevention estimate that "one half of patients in the USA stop taking their medications within one year of being prescribed".

The FDA approved Abilify in 2002 to treat schizophrenia, which affects about one percent of the USA population.

Aripiprazole was initially approved by the FDA in 2002 as a treatment for patients with schizophrenia.


The pill is a variant of the drug Abilify from Otsuka Pharmaceutical Co Ltd.

The sensor "activates when it reaches stomach fluids and communicates with the patch", said the company.

While a patient can block transmissions via a smartphone app, the technology is still likely to prompt questions about privacy. Patients can also grant healthcare providers access to the information through an online portal. In the drug's label, for instance, the FDA noted the wearable patch detects the IEM signal usually within 30 minutes following ingestion. The system is meant to integrate into individuals' lives, and individuals indicate through the app which member (s) of their care team can access information about their medication ingestion, activity, and self-reported mood and rest. "If the MYCITE APP does not indicate that the ABILIFY MYCITE tablet was taken, do not repeat the dose".

In the long run, such digital pills can also be used to manage patients with other complicated treatment routines, such as diabetes or heart conditions.

The FDA says that the ability to track the consumption of prescribed medicines for mental illness may be useful "for some patients", although the ability of digital pills to improve patient compliance has not been proven.

"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", said Mitchell Mathis of the FDA's Center for Drug Evaluation and Research. Patients should be monitored for worsening and emergence of suicidal thoughts and actions.

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