The new drug application (NDA) was filed for a modified version of Otsuka Pharmaceutical Co.’s previously approved anti-psychotic Abilify, this time combined with a transmitter made by Proteus Digital Health.
Each tablet contains an ingestible sensor – which has separately been cleared by the FDA – which sends a signal after it reaches the stomach to an external patch worn by the patient. The patch records and time-stamps the information, and collects other metrics, including the patient’s rest, body angle and activity. This data is relayed to patients on a mobile phone or Bluetooth device, and with consent, can be sent to their doctor.
The creators say the drug-device combination provides an objective way to measure medication adherence and physiologic response. About half of patients with chronic diseases in developed countries do not stick to their prescribed regimen, according to a WHO study.
The Abilify tablet is combined with a wearable patch and software for measuring adherence in the treatment of adults with schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and adjunct therapy for adult major depressive disorder.
“Today, patients suffering from severe mental illnesses struggle with adhering to or communicating with their healthcare teams about their medication regimen, which can greatly impact outcomes and disease progression,” said William Carson, CEO of Otsuka Pharmaceutical Development & Commercialization, Inc.
“We believe this new Digital Medicine could revolutionize the way adherence is measured and fulfil a serious unmet medical need in this population. We look forward to continuing working with the FDA throughout the NDA review.”
The sensor is “a food-particle-sized device comprised of an integrated circuit (IC) with layers of minerals on two sides,” according to to a draft document from the European Medicines Agency (EMA) on Proteus's part of the invention.
The sensor by itself was CE-marked in 2010 in the EU as a class IIa medical device (CE # 559373) and cleared in 2012 for marketing in United States (DEN120011).
When swallowed, the sensor produces a short signal powered by a biogalvanic battery, and a unique identified code. This signal travels through the body, where it is detected by an external medical device, such as Proteus’s wearable sensor, which can be stuck to the abdomen.
The application has been filed across several US FDA divisions, involving the FDA Center for Devices and Radiological Health (CDRH), which has already approved Proteus’s sensor on its own, and the FDA Center for Drug Evaluation and Research (CDER).
According to the EMA document, the sensor-drug combination is “unique in that the drug component and device component function completely independently of one another – the drug provides its pharmacologic effect as it would if administered singly, while the device signals that it has been ingested just as would be the case if swallowed independently.”
Proteus plans to combine its sensor with already approved medical devices, such as its own wearable digital tech, to record data.