Drug Adherence Device Developed By Proteus and Otsuka, Awaits FDA Approval

Otsuka and Proteus Digital Health have developed a drug adherence combo device to monitor how patients are taking their medications. Proteus received FDA clearance for its sensor pill earlier this year, and the team has just submitted an application for their drug adherence device.

The partnership combines Proteus’ ingestible sensor and Otsuka’s psychiatric medication, Abilify, which are packaged together in a single pill. The embedded sensor records data on how the pharmaceutical – which is prescribed for schizophrenia, and other sever forms of mental illness – is taken by the individual.

The wearable drug adherence patch receives data from the ingestible sensor once it has reached the stomach, which is then transmitted to a Bluetooth device, such as a mobile phone. Along with recording the time at which Abilify is taken, the device collects other health metrics including activity patterns, level of rest and body angle. This data is able to provide caregivers with a better idea of how the patient is taking this medication, and whether they are adhering to the prescribed treatment schedule.

It is estimated that in developed countries, 50 percent of people with chronic conditions do not take their medications as prescribed. Improving drug adherence could potentially save $100 to $300 billion in needless healthcare costs in the US alone, according to the companies.

William Carson, president and CEO of Otsuka’s pharmaceutical development and commercialization unit said, “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. We believe this new Digital Medicine could revolutionize the way adherence is measured and fulfill a serious unmet medical need in this population. We look forward to continuing working with the FDA throughout the NDA review.”

Proteus continues to make deals and secure new sources of financing in order support the development of the device. One of the biggest digital health financing deals of the year was made when the California-based company raised $172 million.

Proteus has also announced its intentions to collaborate with Oracle, to combine its ingestible sensor into the company’s clinical trial management software set-up. The plan is to increase the success of clinical trials by gathering more accurate data about patient adherence, and the safety and efficacy of the drug being investigated.

Sources:

• Proteus and Otsuka head to FDA with drug adherence combo device – http://www.fiercemedicaldevices.com/story/proteus-and-otsuka-head-fda-drug-adherence-combo-device/2015-09-10