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

Henrietta Strickland
November 14, 2017

Officials with the US Food and Drug Administration have approved aripiprazole tablets with a sensor to digitally track whether patients with schizophrenia, bipolar I disorder, and depression have taken their medication (Abilify MyCite).

The pill's sensor sends a message to a wearable patch that transmits the information to an app, allowing patients to track the medication's ingestion on their phone. Patients can also permit their caregivers and physician to access the information through a web-based portal.

Abilify MyCite contains a Boxed Warning alerting health care professionals that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Patients should be monitored for worsening and emergence of suicidal thoughts and actions. 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. Abilify was approved ten years earlier. Additionally, the medication has been associated with increased suicidal thoughts and behavior in children, adolescents, and young adults taking antidepressants. The safety and effectiveness of Abilify MyCite have not been established in pediatric patients.

The system offers doctors an objective way to measure if patients are swallowing their pills on schedule, opening up a new avenue for monitoring medicine compliance that could be applied in other therapeutic areas.

The most common side effects reported by adults taking Abilify were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body, anxiety, insomnia, and restlessness. The common adverse events associated with the sensor were related to the patch, and were predominantly skin irritation.

Abilify on its own had received FDA's approval in 2002 for the treatment of schizophrenia. Otsuka collaborated with Proteus Digital Health, the Silicon Valley company that designed the futuristic sensor technology. The sensor that is used along with the medication was first cleared for use by the FDA in 2012; however, the approval of the pill and the sensor together represents a milestone for the FDA. 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.

Other reports by Click Lancashire

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