FDA Wants More Info on Smart Pill-Abilify Combo

Proteus Digital Health has been working with Otsuka Pharmaceutical to package the antipsychotic drug with Proteus' technology for tracking whether patients are taking their meds.

Chris Newmarker

Proteus Digital Health and Otsuka Pharmaceutical appear to be facing a setback when it comes to combining Otsuka's Abilify antipsychotic drug with the Proteus ingestible sensor to track whether the medication is actually being taken.

FDA has requested extra information for the new drug application for the Digital Medicine drug/device combination product, the two companies said Tuesday.

Information requested includes data about the performance of Digital Medicine under the conditions in which it will likely be used. FDA also wants human factors investigations to evaluate use-related risks.

"While we are disappointed in the FDA's decision not to approve this Digital Medicine at this time, both Otsuka and Proteus are committed to working with the FDA to address its questions and provide the additional data that has been requested," Robert McQuade, executive vice president and chief strategy officer at Otsuka Pharmaceutical Development & Commercialization, said in a news release.

"We believe in the potential of this product to help people with serious mental illness manage their daily medication, which remains a serious unmet need," McQuade said.

The NDA is for a system to track medication adherence for schizophrenia patients, as well as an acute treatment of manic and mixed episodes associated with bipolar I disorder and an adjunctive treatment for major depressive disorder.

The combo drug-device product is an Abilify tablet containing an ingestible sensor that communicates with a wearable sensor patch. Medical software measures whether Abilify is being taken as it is supposed to be.

The Proteus ingestible sensor and wearable patch are already FDA cleared.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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