FDA approves first 'trackable' pill Abilify

FDA approves the first pill that can alert your doctor when you swallow it

On Nov. 13, 2017, FDA announced it has approved Abilify MyCite (Otsuka Pharmaceutical Co., Ltd.), which is the first drug in the United States that has a digital ingestion tracking system.

This patch then transmits the information to a mobile app, so that a doctor and up to four caregivers, friends or family members can see the information through a web-based portal. It can also be used in the acute treatment of manic and mixed episodes associated with bipolar I disorder so it has the potential to do a whole lot of good.

"The FDA supports the development and use of new technologies in prescription drugs, and is committed to working with companies to understand how technology can benefit patients and prescribers", said Mitchell Mathis of the FDA's Center for FDA Drug Evaluation and Research. The sensor is able to track when the pill was taken, the dosage, and a plethora of other metrics similar to the information a fitness tracker might gather, such as activity levels, sleep patterns, and heart rate.

Abilify MyCite is not approved to treat patients with dementia-related psychosis and 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.

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Abilify MyCite's future isn't certain, however. This medication is described as a 'digital pill, ' one that features both the medicine and an embedded sensor.

Patients taking Abilify MyCite should be monitored for worsening or emerging suicidal thoughts and behaviors. Some use email and text reminders, while others have turned to devices such as smart pill bottles that keep track of how much medication a patient has gone through. The medication must also be dispensed with a patient Medication Guide with information about the drug's uses and risks. "Abilify MyCite should not be used to track drug ingestion in "real-time" or during an emergency because detection may be delayed or may not occur". Otsuka collaborated with Proteus Digital Health, the Silicon Valley company that designed the futuristic sensor technology. 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.

Abilify was first approved by the FDA in 2002 to treat schizophrenia.

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