With new digital Abilify, Big Brother isn't watching—but your mother could be

A new digital version of Abilify is the first-ever pill to notify patients that they've swallowed it. It may be the first in a wave of dose-tracking drugs that could appeal to patients who forget to take their pills and to payers looking to get their money's worth out of their members' prescriptions.

The pill and its digital companions, now FDA-approved as Abilify MyCite, aren't likely to make a big difference to Otsuka's Abilify sales—certainly not immediately, given its plans for a limited initial launch. The atypical antipsychotic drug is already available as a cheap generic, and doctors are already using an injectable, long-lasting version—Abilify Maintena—to manage patients who have problems sticking to a daily pill regimen. Payers may be wary of the costs.

Then there's the fear factor. The pill and its companion smartphone app allow doctors—and anyone else the patient designates, for that matter—to track their dosing. Those tracking capabilities, which rely on an app that also lets patients record their mood, sleep and exercise, have stirred some anxiety. Some worry that the technology could be used to spy on people or coerce them into drug therapy.

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But adherence to prescribed dosing is a big problem, one that some drugmakers have tried to battle for years; patients who don't take their medications don't refill their prescriptions. It's a pocketbook problem for payers that foot the bill for a prescribed drug and then pay to treat problems the drug was designed to prevent.

In the case of Abilify, a patient who doesn't stick to the drug could end up in a psychiatric hospital, so Abilify MyCite may find its niche. Psychiatric patients have particular problems sticking to their medications, and some of them might prefer a smart pill and phone app to an injection.

And Otsuka is aware that Abilify MyCite is a more complicated product than the usual pill, and it'll be more difficult to market, too. The drugmaker plans a small launch at first, so it can see how the digital-smart pill system works in the real world.

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"[H]aving fewer people using the system initially means their prescribers, health plans, and Otsuka can focus on learning from these patients’ experiences," the company said in its announcement. "This initial limited rollout will be a crucial step in determining Otsuka’s broader go-to-market plan."

Though Abilify pills are already available as generics, Otsuka has been working on broadening the list of approvals for the long-lasting injectable version. The injection won a new use in bipolar disorder this year.

The Abilify MyCite approval is a bigger breakthrough for Proteus, which has been working on drug-device combo pills for years. This first U.S. approval could bode well for other new products in the works, including sensor-embedded versions of generic blood pressure pill lisinopril and the standard diabetes drug metformin.

It was Otsuka and Proteus' second try at the FDA for the digital version of Abilify. The agency rejected the drug-device combo last April, and the two companies resubmitted their application in May.