Science

FDA approves first ever 'digital pill'

FDA approves first ever 'digital pill'

The decision approves the Ability MyCite system as a whole - both Abilify and Proteus Health's sensor and patch had previously been cleared individually in the US.

The Food and Drug Administration has approved the first drug in the United States to come with a digital ingestion tracking system.

"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", the FDA said in the November 13 statement.

"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", added Mitchell Mathis, M.D. Psychiatric Products Division director for the Center for Drug Evaluation and Research at the FDA. For one, compulsory court-ordered medical treatment of disorders runs into civil rights territory (though advocates say it's effective), and a sensor-equipped pill will let anyone with access to the data know exactly how often someone is taking their medication.

Failure to take medications as prescribed is said to not only result in higher rates of mortality, but to result in billions of dollars of additional healthcare costs through such occurrences as more frequent admission rates of patients with chronic conditions.

It was Otsuka and Proteus' second try at the FDA for the digital version of Abilify.




Otsuka shares rose 2.5 percent on Tuesday after news by the US Food and Drug Administration (FDA) late Monday.

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

Only functions of the app related to tracking drug ingestion have been approved by the FDA. 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". Web-based dashboards are provided to healthcare providers and caregivers to view a summary of the information. In the drug's label, for instance, the FDA noted the wearable patch detects the IEM signal usually within 30 minutes following ingestion. If the MyCite app is unable to show if the pill was ingested, a repeat dose is not advised.

Using Abilify MyCite to track drug use in real time or in the event of an emergency is not ideal, however, as there may be a delay or problem in the detection. Patients should be monitored for worsening and emergence of suicidal thoughts and actions.

The study found this a "feasible method to measure real-time opioid ingestion patterns in individuals with acute pain and to develop real-time interventions if opioid abuse is detected".


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