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FDA approves first drug with digital ingestion tracking system

14 Novembre 2017

It might sound creepy, but U.S. regulators have approved a drug that can digitally track whether patients have taken their medicine.

The US Food and Drug Administration on Monday approved the first drug in the US with a digital ingestion tracking system. However, the medication is geared only for people diagnosed with certain kinds of mental illness. The symptoms of bipolar disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior and a decreased need for sleep.

Prior to initial patient use of the product, the patient's health care professional should facilitate use of the drug, patch and app to ensure the patient is capable and willing to use the system.

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Sensors, developed by Proteus Digital Health, are embedded in the pills and activated by stomach juices. The sensor transmits signals to a wearable with an electrode in the form of a skin patch.

Abilify was first approved by the FDA in 2002 to Otsuka Pharmaceuticals for the treatment of schizophrenia. "The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers". Monday's hard-won approval could come as a big boost for Otsuka, which had lost market share after Abilify went generic but will now have a way to make the product stand out. With the patient's consent, that data can then be shared with a doctor and family members to help manage the mental illness, Proteus has said in past statements, lobbying for the FDA to approve the drug. Comedian Stephen Colbert lampooned the tech back in 2012, joking, "Nothing is more reassuring to a schizophrenic than a corporation inserting sensors into your body".