FDA: More Data Needed on Proposed Treatment for Schizophrenia

The U.S. Food and Drug Administration (FDA) has told the manufacturers of a drug and device combination that they must provide more information before the product can be considered for approval. The product, Digital Medicine, has been developed as a treatment for schizophrenia and other mental illnesses. The Complete Response Letter was announced by the manufacturers, Otsuka Pharmaceutical Co. and Proteus Digital Health.

“While we are disappointed in the FDA’s decision not to approve this Digital Medicine at this time, both Otsuka and Proteus are committed to working with the FDA to address its questions and provide the additional data that has been requested,” said Robert McQuade, executive vice president and chief strategy officer for Otsuka Pharmaceutical Development & Commercialization. “We believe in the potential of this product to help people with serious mental illness manage their daily medication, which remains a serious unmet need.”

Digital Medicine is a tablet that combines aripiprazole, an atypical antipsychotic, with an ingestible sensor that measures patients’ adherence to the drug. The sensor has already been cleared by the FDA, according to the manufacturers.

Otsuka and Proteus submitted the product to the FDA as a treatment for schizophrenia, as well as for acute treatment for manic and mixed episodes associated with bipolar disorder and as an adjunctive treatment for depression.

The additional information requested by the FDA includes data on the performance of the product under the conditions in which it is likely to be used. The FDA also requested further human factors investigations, which evaluate risks from using the product and confirm people can use it safely and effectively.

—Terri Airov

Reference

FDA Issues Complete Response Letter for Digital Medicine New Drug Application [press release]. Business Wire. 2016 April 26.