Health Care

FDA approves first digital drug to track if you take your meds

FDA approves first digital drug to track if you take your meds”

Following the doctor's orders might soon be unavoidable advice.

The U.S. Food and Drug Administration approved a joint application by Proteus Digital Health and Otsuka Pharmaceutical for a medication monitoring tool for patients taking Otsuka's drug Abilify.

The drug is approved for the treatment of bipolar I disorder characterized by the occurrence of at least one manic or mixed episode, schizophrenia, and add-on treatment for depression in adults. If a patient opts to allow it, the patient's caregivers and doctor can access the data online, too. But the new product will also be labeled with a caveat: There's no evidence that the technology can help patients take their medication as prescribed.

"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients", said Mitchell Mathis, director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. It noted that the ability of the sensors to track the patient's compliance with their treatment regimen "has not been shown".

Schizophrenia is a chronic, severe and disabling brain disorder, and its symptoms include hearing voices, believing other people are reading their minds or controlling their thoughts, making them suspicious or withdrawn.

Aripiprazole is approved with a boxed warning concerning an increased risk of death when used as a treatment for elderly patients with dementia-related psychosis. Additionally, the medication has been associated with increased suicidal thoughts and behavior in children, adolescents, and young adults taking antidepressants. The sensor technology and patch are made by Proteus Digital Health.

In clinical trials establishing the efficacy of aripiprazole, the most common adverse events were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness.

Called Abilify, the purely chemical version of the drug actually received FDA approval over a decade ago to treat patients with schizophrenia and bipolar disorders. The common adverse events associated with the sensor were related to the patch, and were predominantly skin irritation. In September, the FDA approved the first mobile app to treat certain substance use disorders, developed by the Boston company Pear Therapeutics. 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.



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