26 April 2016 - Otsuka and Proteus Digital Health today announced that the US FDA has issued a complete response letter for their digital medicine, a drug/device combination product, which combines Otsuka’s Abilify (aripiprazole), an atypical antipsychotic, with the FDA cleared Proteus Digital Health ingestible sensor embedded in a single tablet at point of manufacture.

The new drug application was submitted for an indication to measure medication adherence to aripiprazole in adults as a treatment for schizophrenia, as an acute treatment of manic and mixed episodes associated with bipolar I disorder and as an adjunctive treatment for major depressive disorder.

The FDA has completed its review and has requested additional information, including data regarding the performance of the product under the conditions in which it is likely to be used, and further human factors investigations. The goal of human factors testing is to evaluate use-related risks and confirm that users can use the device safe and effectively.

For more details, go to: http://www.otsuka-us.com/newsroom/Pages/NewsArticle.aspx?ItemId=23