U.S. FDA Accepts First Digital Medicine Application; Technology Combines Abilify With Proteus Sensors

On September 8, 2015, the United States Food and Drug Administration (FDA) accepted a new drug application (NDA) for a drug-device for measuring adherence to antipsychotic treatment for adults with schizophrenia, bipolar disorder, or major depressive disorder. The NDA was submitted by Otsuka and Proteus Digital Health, Inc. for an oral tablet that combines Otsuka’s branded antipsychotic Abilify (aripiprazole) with an embedded ingestible sensor device that digitally records ingestion. With the consumer’s consent, the sensor communicates with a wearable sensor patch and a medical software application to share information with the consumer’s care team about when . . .