UPDATED: FDA rejects Otsuka, Proteus pill with medication adherence monitoring

Ingestible sensor pill, patch and iPad app--Courtesy of Proteus

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.

"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."

Abilify (aripiprazole) is an atypical antipsychotic. The submitted NDA was for a system that measures medication adherence to aripiprazole to be indicated for the treatment of schizophrenia, as an acute treatment of manic and mixed episodes associated with Bipolar I Disorder and as an adjunctive treatment for Major Depressive Disorder.

The Otsuka drug already faced U.S. patent expiry in April 2015; its competitors market generic versions. The companies would offer an upgraded, somewhat differentiated product. The idea is that patients with mental illness, whose day-to-day functioning depends upon adherence to their medication, are a good initial target and proving ground for the Proteus technology, but the FDA wants more confirmation before it's ready to sign off on that premise.

"Otsuka and Proteus believe that having greater insight into actual medication-taking patterns gives people living with mental illness greater insight into their medication adherence, which may ultimately help them – and their families and healthcare providers – make more informed decisions about their care," the companies told FierceMedicalDevices via email.

Proteus raised $50 million in a Series H financing last month, bringing its total raised to more than $220 million, to finance the marketing of this technology. A clear regulatory win on this drug combo might have made the startup a more appealing acquisition target--or given it more revenue to appeal to Wall Street with an IPO.

- here is the announcement