FDA Accepts NDA for Abilify with Ingestible Sensor

Sep 15 2015

—Amanda Pedersen, Senior Staff Writer, Medical Device Daily, September 15th, 2015

Digital technology has advanced to the point of allowing pharmaceutical companies to make drugs that, in a sense, can outsmart patients.  The FDA recently accepted a new drug application (NDA) for the combination product of Otsuka Pharmaceutical’s (Tokyo) Abilify (aripiprazole), embedded with an ingestible sensor in each tablet to objectively measure whether or not a patient has taken their medication. The company said it is the first time an FDA-approved has been combined and submitted for approval with a sensor within the medication tablet to measure actual patterns and physiologic response.

Abilify is used to treat mental illnesses including major depressive disorder, bipolar disorder and schizophrenia.

Bob McQuade, executive VP and chief strategy officer at Otsuka America Pharmaceutical said the ingestible sensor developed by Proteus Digital Health (Redwood City, Calif.) has the potential to allow patients and their caregivers and doctors to know if they have or have not taken their medication.

“In serious mental illness, non-adherence to medication is a huge issue,” McQuade told Medical Device Daily. “People stop taking their drugs, they often then relapse and each relapse then worsens the prognosis for the future recovery of the patient.”

The addition of the ingestible sensor can not only remind patients to take their medication, but also is important
information for doctors because it will tell them if the patient is not responding to the drug because they are not taking it or if they are not responding because they are not taking the medication.

“We see it as really groundbreaking,” McQuade said.

The Proteus sensor, after it is ingested, sends a signal to a patch worn on the patient’s abdomen, which then sends a
signal to a cell phone that can deliver the information to the patient and ultimately, with the patient’s consent, to their
physician and caregivers.

“The whole world is going digital,” said Andrew Thompson, President/CEO of Proteus Digital Health. “Most of the common experiences in our daily lives are becoming digital events.” Human interaction is shifting, Thompson said, from things that were once about buildings, people and products into interactions that are increasingly about software, services and mobile devices. Proteus has developed a broad platform technology designed to enable Proteus and its pharmaceutical industry partners to integrate ingestible, wearable, mobile and cloud computing.

“What we’re doing with the ingestible computer in particular is to turn drugs into the on-ramp to digital health,” Thompson said. “It is the engagement transaction that takes the consumer into the digital world and has them start to interact with information about their own body and how they’re using their own drugs and that’s an incredibly powerful effect.”  It helps people make much more appropriate individual health decisions and it also helps create a data stream that can then be used by physicians to more appropriately manage risk across their panel, Thompson said.

In the future, the technology could easily find its way into other medications for other patient populations. “We all forget to take our medication or we all have that day where you can’t remember if you took it or if you didn’t,”
McQuade said. “It has very broad applicability across virtually all disease states for all patients, but in mental health, it’s especially keen since adherence is such a huge issue.”

When patients struggle with appropriate use of medication, Thompson said people in the health care industry sometimes imply that it’s the patient’s problem, but his company sees it differently. “It’s not really a problem with the patient it’s a product design problem that you can solve with engineering,” he said.

“What we know about people in any human system is that in open loops they don’t do very well. If you sent your kids to a school where they never took a test, they never had homework graded and they never got to pass a class, they probably wouldn’t learn very much,” Thompson said. “But that is what we typically expect patients to do in chronic disease settings.  They get very little support, they don’t get any measurement about their health behaviors except maybe at clinic visits, they don’t get any feedback and they don’t get any behavioral cues.”

Proteus’ solution is designed to provide measurement, feedback and behavioral cues, he said, which makes it much
more likely that patients will succeed in managing their own chronic conditions. Abilify is already an FDA-approved drug, and each device   component of the Proteus system has been cleared by the FDA.  As a drug-device combination, the product is now subject to FDA approval once more, filed as an NDA, before the ingestible
sensor can be embedded at the point of manufacture with the drug.

“Now we’re going to the agency and asking them to bring these two things together and their concerns are basically stability of a tablet as well as the ability of patients to follow instructions for use,” McQuade said.