FDA accepts NDA for first 'digipill'

September 22, 2015

Proteus Digital Health along with the pharmaceutical company, Otsuka, has submitted the first Digital Medicine New Drug Application (NDA) for the combination tablet of Abilify (aripiprazole) embedded with a Proteus ingestible sensor.

FDA has accepted a New Drug Application for the combination drug/device product (Digital Medicine) of aripiprazole (Abilify, Otsuka) embedded with a Proteus Digital Health ingestable digital sensor in a single tablet.

Related: FDA approves first generic Abilify

This is the first time an FDA-approved drug has been combined and submitted for approval with a sensor within the drug's tablet to measure actual medication-taking patterns and physiological response. The information is communicated to the patient-and with the patient's consent-to the patient's physician or caregiver.

According to Proteus, almost half of all patients in developed countries fail to take their prescriptions as prescribed and the total cost of this loss to the US healthcare system may result in an estimated $100 billion to $300 billion in avoidable healthcare costs. Digital Medicines are expected to enable improved medication adherence and informed physician decision-making to tailor treatment to patient’s specific needs.

Related:FDA moves forward with approval of generic Abilify from 4 different manufacturers despite Otsuka pushback

The sensor in Digital Medicine communicates with a wearable sensor patch and a medical software application for measuring adherence in the treatment of adults with schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and as adjunctive therapy for the treatment of major depressive disorder in adults.

“Digital Medicines have the potential to move healthcare beyond the proven efficacy of a medicine to understand the real-world effectiveness of a therapy for each individual,” said Andrew Thompson, president and CEO of Proteus Digital Health, in a press release. “This means that medicines could be tailored to each of us to reflect our unique medication-taking patterns, lifestyle and daily health choices.”

The “digipill” is especially useful for the treatment in patients who have substantialy compromised medication adherence behavior, such as those with memory disorders, such as Alzheimer’s, schizophrenia, and other diseases.

“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 H. Carson, MD, president and CEO of Otsuka Pharmaceutical Development & Commercialization, Inc., in a press release.

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