First digital medicine application accepted by FDA

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The United States Food and Drug Administration (FDA) accepted a new drug application for a drug-device for measuring adherence to antipsychotic treatment for adults with schizophrenia, bipolar disorder, or major depressive disorder. The Digital Medicine, first in the world, is a drug/device product that combines Otsuka’s ABILIFY® (aripiprazole) for serious mental illness, embedded with the Proteus® ingestible sensor in a single tablet to digitally record ingestion and, with patient consent, share information with their healthcare professionals and caregivers. With the consumer’s consent, the sensor communicates with a wearable sensor patch and a medical software application to share information with the consumer’s care team about when the medication was taken. The system also tracks the consumer’s physiological responses, such as sleep patterns and physical activity levels. 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*1,*2. For example, patients suffering from chronic mental disorders such as schizophrenia are often required to take medication for long periods, and it is not unusual for these patients to discontinue taking their medication, or not take their medication as prescribed, which can lead to disease relapse and recurrence.

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