The FDA issued a complete response letter regarding a marketing application for a drug-device product combining Otsuka's atypical antipsychotic Abilify (aripiprazole) with Proteus Digital Health's ingestible sensor, the companies said. The filing, the first such application to be reviewed by the agency, was submitted as a system that measures medication adherence to Abilify when used as a treatment for schizophrenia, as an acute treatment of manic and mixed episodes associated with bipolar I disorder and as an adjunctive therapy in major depressive disorder.
According to Otsuka and Proteus, the FDA requested additional information, including data about the product's performance under the conditions in which it is likely to be used. The regulator has also asked for more "human factors" testing, which the companies said aims to evaluate use-related risks and to confirm that the device can be used safely and effectively.
"While we are disappointed in the FDA's decision...both Otsuka and Proteus are committed to working with the FDA to address its questions and provide the additional data that has been requested," remarked Robert McQuade, chief strategy officer at Otsuka's development and commercialisation division.
Proteus' ingestible sensor technology was originally approved by the FDA in 2012 for use to be integrated into an inert tablet or other ingested product, such as a drug, and was expanded last year to include monitoring drug adherence. The ingestible sensor received the CE mark in 2010.
Otsuka and Proteus entered into a global agreement in 2012 to develop and promote new drugs based on Otsuka's pharmaceutical products and Proteus' digital health feedback system that incorporates its sensor-based technologies. Meanwhile, Novartis is also partnered with Proteus to develop sensor-based pharmaceuticals.
For related analysis, see Spotlight On Interview: Can a microscopic sensor-in-a-drug revolutionise patient adherence? – FirstWord discusses this breakthrough technology with Proteus CEO Andrew Thompson and Otsuka US executive vice president Bob McQuade.
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