First digital medicine starts its journey with the FDA

Abilify bottle

The New Drug Application (NDA) for the combination product of ABILIFY (aripiprazole) embedded with a Proteus ingestible sensor in a single tablet is sufficiently complete to allow for a substantive review, FDA has determined.

Otsuka Pharmaceutical and Proteus Digital Health shared the news, adding that this is the first time an FDA-approved medication (ABILIFY) has been combined and submitted for approval with a sensor within the medication tablet (the Proteus ingestible sensor) to measure actual medication-taking patterns and physiologic response. This information is communicated to the patient as well as to his/her physician and/or caregiver.

“We believe this new Digital Medicine could revolutionize the way adherence is measured and fulfill a serious unmet medical need in this population,” said William H. Carson, M.D., president and CEO of Otsuka Pharmaceutical Development & Commercialization, Inc. “We look forward to continuing working with the FDA throughout the NDA review.”

If approved by the FDA, Proteus’ ingestible sensor will be embedded at the point of manufacture with ABILIFY as a combination drug-device, communicating with the Proteus patch and associated medical software.

Digital Medicines have the potential to improve patient medication adherence and enable better informed physician decision-making to tailor treatment to the patient’s needs.ABILIFY is an antipsychotic medicine used to treat the symptoms of schizophrenia and bipolar disorder.

Digital Medicines have the potential to improve patient medication adherence and enable better informed physician decision-making to tailor treatment to the patient’s needs. “This means that medicines could be tailored to each of us to reflect our unique medication-taking patterns, lifestyle and daily health choices,” according to Andrew Thompson, president and CEO of Proteus Digital Health.

An estimated average of 50% of patients with chronic diseases in developed countries do not take medicines as prescribed, possibly limiting the effectiveness of those medicines. In the U.S., this may result in an estimated $100-300 billion in avoidable healthcare costs due to direct costs such as unnecessary escalation of treatment as well as indirect costs.