A drug company developing the first "digital pill" has had its drug application approved by the FDA.
The FDA approved the New Drug Application (NDA) that allows the drug ABILIFY to be embedded with a Proteus ingestible sensor in a single "smart" tablet.
The Proteus device itself was approved by the FDA in June, and the NDA marks the first time the sensor will be combined with an approved drug to be used as a digital medicine.
ABILIFY is prescribed to adults with schizophrenia, bipolar disorder, or Major Depressive Disorder.
The smart pill will measure a patient's pattern of taking medicine and the body's physiologic response.
Experts hope the new pill will help patients take medicine as prescribed, and also help doctors tailor treatments to each patient's needs.
When the smart pill enters the stomach, it begins communicating with a patch worn on the patient's arm.
The patch records and time-stamps the information from the sensor and collects other information, and then relays it to patients on a mobile phone or other Bluetooth-enabled device.
With the patient's consent, the information is also shared with the doctor.
Experts hope the new pill will help patients take medicine as prescribed, and will also help doctors tailor treatments to each patient's needs.
Only about 50 percent of patients with chronic illnesses take their medicines regularly, which limits their effectiveness and adds billions of dollars in avoidable healthcare costs.
"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 Dr. William H. Carson, president and CEO of Otsuka Pharmaceutical Development & Commercialization, Inc., the company that makes ABILIFY.
"We believe this new Digital Medicine could revolutionize the way adherence is measured and fulfill a serious unmet medical need in this population."
If the treatment itself is eventually approved by the FDA, healthcare professionals will be able to prescribe ABILIFY tablets with the Proteus ingestible sensor embedded in the tablet.
This device can help patients manage symptoms better, while giving caregivers and healthcare professionals the ability to monitor symptoms.
"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, the company that produces the pill.
"This means that medicines could be tailored to each of us to reflect our unique medication-taking patterns, lifestyle and daily health choices."
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