FDA approves Abilify tablets with ingestible sensor

Late Monday, FDA approved Abilify MyCite, which combines the antipsychotic Abilify aripiprazole from Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) with an ingestible sensor from Proteus Digital Health Inc. (Redwood City, Calif.) in a single tablet to digitally track if the medication has been taken. The product is the first FDA-approved digital medicine system.

Abilify MyCite is approved to treat schizophrenia and bipolar I disorder, and as adjunctive treatment of major depressive disorder (MDD). The partners said the ability of the drug-device combination to improve patient compliance or modify dosage has not been established...