Otsuka Pharmaceutical (TYO:4578) and Proteus Digital Health said today that the FDA accepted its resubmitted new drug application for their “smart pill”. The drug-device product combines Abilify and a Proteus ingestible sensor in a single tablet.
The FDA is slated to make a decision on the NDA resubmission in the 4th quarter this year.
After the companies 1st sought approval for the combination product in 2015, the FDA requested further human factors investigations to evaluate use-related risks and to confirm the product’s safety and efficacy.
Proteus’ device is the only FDA-cleared ingestible sensor. The size of a grain of sand, the sensor activates when it reaches stomach fluids and transmits data to a wearable patch that records the ingestion of the Abilify tablet. A mobile app displays the data collected by the patch, enabling patients to review their medication intake and enter self-reported measures.
The drug-device product is designed to provide treatment for adults with schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and as a complementary therapy for major depressive disorder.
The smart-pill also comes with a web-based portal so that healthcare professionals can make informed treatment decisions, according to the companies.
Abilify was the 1st dopamine partial agonist available on the market for schizophrenia. Proteus’ ingestible sensor and wearable sensor patch is cleared by the FDA, CE Marked in the European Union and approved for use in China.