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# Study Finds 1st Digital Med was Approved on Weak Data
- URL: https://www.fdaweb.com/study-finds-1st-digital-med-was-approved-on-weak-data/
- Published: 2019-07-22T12:00:00.000Z
- Updated: 2026-09-15T01:39:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144587

A new study in *BMJ* criticizes the strength of the data on which FDA based its 2017 approval of an Otsuka Pharmaceutical NDA for mental disorder-treating Abilify MyCite (aripiprazole tablets with sensor) — the first drug-device combination in the U.S. with a digital ingestion tracking system. Study researchers say that the product was approved based on “weak evidence, and there was no evidence of better adherence with the digital version of aripiprazole compared with the non-digital version. The possibilities afforded by this technology make room for a new type of evergreening (i.e., patenting of older drugs with a sensor as a ‘new invention’). Both the scientific literature and news reports conveyed an unsupported impression of benefit.”

The pill has a sensor embedded in it that records when the medication was taken. It is approved for treating 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.

“Our review of the clinical trial data submitted to the FDA for the approval of Abilify MyCite reveals that the data submitted were limited to trials that simply assessed whether patients could use the product as intended,” the researchers write. “There was no evidence of superiority or non-inferiority compared with non-digital versions of aripiprazole, other active comparators or placebo, and scarce data on safety. In fact, in the FDA’s clinical review letter, it was noted that the one simulated trial (ie, one in which the participants did not ingest the drug but simply placed the tablets in a container to simulate ingestion), performed for resubmission, ‘provides no additional data regarding adherence or data regarding data transmission times.”

The researchers conclude that the public and healthcare professionals may be making medical decisions based on “industry-friendly, but not necessarily scientifically accurate, information about the efficacy and safety of this new product. Also, if patients are incentivized to take the digital version (e.g., by being offered lower copayments or by being offered outpatient treatment — rather than forced inpatient treatment), the line between incentivizing and coercion will be blurred.”