Otsuka and Proteus announced that the Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for their drug/device product, which combines Abilify (aripiprazole) with an ingestible sensor embedded in a single tablet.
The New Drug Application (NDA) submission was for a system that measures medication adherence to aripiprazole for the treatment of schizophrenia, for the acute treatment of manic and mixed episodes associated with bipolar I disorder, and as adjunctive treatment for major depressive disorder.
After completing its review, the FDA has requested more data on the performance of the product under the conditions in which it is likely to be used, and further human factors investigations. The humans factors testing is intended to assess use-related risks and verify that users can use the product safely and effectively.
Abilify, an atypical antipsychotic, is currently available as 2mg, 5mg, 10mg, 15mg, 20mg, and 30mg strength tablets. The Proteus ingestible sensor and wearable patch are both FDA-cleared for use. When Abilify is taken, the ingestible sensor sends a signal to the wearable Proteus patch after it reaches the stomach. The patch then records and time-stamps the information from the sensor, and documents other patient metrics, including rest, body angle and activity patterns.