The first U.S. regulatory test for a drug that incorporates medication adherence technology has been met with a rejection. The Food and Drug Administration issued a complete response letter to Otsuka Pharmaceutical and Proteus Digital Health for their drug/device combination of Abilify with Proteus' ingestible sensor.
The Proteus technology has already been cleared in the U.S. and Europe for use in conjunction with existing medicines--not, as in this case, with it embedded in a single tablet during manufacturing.
The agency is seeking data on the performance of the product under the specific conditions in which it is likely to be used, as well as further human factors investigations to evaluate use-related risks and confirm that users can use the device safely and effectively, the companies said. They didn't yet disclose a timeline for a resubmission of the drug/device combo to the FDA.
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"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," said Otsuka EVP and chief strategy officer Robert McQuade in a statement. "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."