US regulators have rejected Digital Medicine - a drug/device system in which Otsuka’s antipyschotic Abilify is embedded with Proteus’ ingestible sensor - for the treatment of psychiatric disorders, asking for more information.
Digital Medicine has been developed to enable digital recording of the pill’s ingestion, so that, with patient consent, this information can be shared with healthcare professionals and caregivers, with a view to improving adherence, a key treatment goal.
The companies are seeking approval for the product for the treatment of schizophrenia, as an acute treatment of manic and mixed episodes associated with Bipolar I Disorder (BP1) and as an adjunctive treatment for Major Depressive Disorder (MDD).
But in a response letter the US Food and Drug Administration said it required additional data, including regarding the performance of the product under the conditions in which it is likely to be used, and further human factors investigations, before it would re-consider approval.
http://www.pharmatimes.com/Article/16-04-27/FDA_rejects_antipyschotic_drug_device_combo.aspx