Digital Abilify pill secures first-of-its-kind FDA approval
- The Food and Drug Administration has approved for the first time a drug embedded with a digital sensor that can tell patients, caregivers and physicians when it has been taken.
- Abilify MyCite comes in the form of a pill, outfitted with what's called an Ingestible Event Maker (IEM). Once swallowed, the IEM sends a signal indicating the drug is in the patient's body to a wearable patch, which in turn passes the information along to a smartphone application.
- The drug-device combination is approved for several of the same indications as regular Abilify, including schizophrenia, add-on therapy for depression in adults, and. acute treatment of manic and mixed episodes associated with bipolar I disorder.
Of the many hurdles drugmakers face — mastering complex science, navigating regulations, crafting successful marketing campaigns — patient adherence remains one of the most difficult to clear. While the rates at which patients deviate from their treatment regimens vary, estimates hold such actions cost the U.S. healthcare system hundreds of billions of dollars each year.
Technology has been a vital tool for manufacturers and healthcare providers looking to improve patient adherence. 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.
Applying technology directly into the medicines themselves is a more cutting-edge approach, but one that is clearly gaining traction, as evidenced by the FDA's approval of Abilify MyCite (aripiprazole tablets with sensor).
"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients," Mitchell Mathis, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in a Monday statement. "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."
Abilify MyCite's future isn't certain, however. In the drug's label, for instance, the FDA noted the wearable patch detects the IEM signal usually within 30 minutes following ingestion. But that time may extend to as long as two hours, and in some cases never come through at all. Whether this new drug-device combo will actually prop up adherence is also quite unclear.
"It is important to note that Abilify MyCite’s prescribing information (labeling) notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown," the FDA said in the Nov. 13 statement. 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."
Should prescribes take to Abilify MyCite, the new formulation could help Abilify's maker Otsuka Pharmaceutical Co. Ltd. The Japanese pharma reported Abilify sales of ¥53.6 billion (about $479 million) for the first nine months of 2017, down 30% from the same period in 2016.
In prescribing Abilify MyCite, physicians must make sure patients download the corresponding mobile application on their smartphones and are comfortable using it, since that is how they will ultimately view the information provided from the drug-device combo. Patients can also grant healthcare providers access to the information through an online portal.
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