Otsuka, Proteus win FDA approval for digital medicine

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The FDA approved Abilify MyCite at the second time of asking.

Otsuka and Proteus Digital Health have won FDA approval for their digital medicine. The approval clears Otsuka to start selling a sensor-enabled version of its schizophrenia drug Abilify designed to improve compliance.

The product, Abilify MyCite, is a combination of Otsuka’s treatment for schizophrenia and Proteus’ adherence-tracking sensor, which won approvals individually in 2002 and 2012, respectively. The sensor sends a signal when it comes into contact with liquid in the stomach. This signal is detected by a wearable patch that relays the date and time the pill was taken to a smartphone app, which, in turn, can share the information with doctors and family members. 

Proteus gained clearance to sell standalone digital pills and patches years ago but this week’s nod marks the first time the FDA has approved a medicine that incorporates its technology. Combining the technology and medicine into a single product frees the patient from the need to remember to take a second pill and makes it more likely that a signal corresponds to the consumption of the drug.

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Otsuka and Proteus tried to win approval for the combined product once before but were knocked back by the FDA. The 2016 complete response letter called for more data showing the targeted patient population can use digital pills safely and effectively.

In approving the revised application, the FDA said healthcare professionals should ensure the patient is willing and capable of using the drug, patch and app before prescribing the product. 

RELATED: Otsuka, Proteus refile for FDA approval of digital medicine

Otsuka now faces the task of persuading people to use the digital pill over generic competitors. In making its pitch, Otsuka can point to studies that estimated nonadherence in schizophrenia patients is 50%. That translates into poorer outcomes for patients and wasted expenditure for payers. 

However, given some noncompliance stems from paranoia about the doctor and their intentions, some have questioned whether schizophrenia is the best proving ground for the technology. 

“A system that will monitor their behavior and send signals out of their body and notify their doctor? You would think that, whether in psychiatry or general medicine, drugs for almost any other condition would be a better place to start than a drug for schizophrenia,” Paul Appelbaum, M.D., director of law, ethics and psychiatry at Columbia University, told the New York Times.

Otsuka plans to introduce the product next year, starting initially with select healthcare plans.