FDA Accepts NDA for First-Ever Digital Medication

Otsuka Pharmaceuticals and Proteus Digital Health released a joint statement on September 10 revealing the Food and Drug Administration accepted their new drug application for the first sensor-embedded version of Abilify for depression.  

Here’s how this hybrid drug/device product works: An ingestible sensor built into the tablet works with another sensor embedded into a wearable adhesive patch to monitor a patient’s medication-taking patterns as well as their physiological responses like rest, body angle, and activity patterns, writes MobiHealthNews. 

The collected information can be viewed on a smartphone or other Bluetooth-enabled devices. Patients may give permission to have this data sent securely to physicians and/or caregivers.