First sensor-pill combo approved, but better compliance unproven

The US FDA’s approval of the world’s first “digital medicine” – a form of Otsuka’s schizophrenia pill Abilify incorporating a minute sensor that informs a doctor when a patient takes the drug – could have profound effects on both the pharma and medtech worlds. For Otsuka, the product will be a useful understudy to Abilify Maintena, the long-acting injectable version of the original pill, which is now generic.

For the sensor’s developer, Proteus Digital Health, the approval means the chance to form other lucrative partnerships to develop new sensor-pill combos. And, if the use of this type of sensor can be proven to improve patients’ compliance with drug treatment, this approval might be the first of many. The trouble is that so far, no such proof exists.

Abilify MyCite is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and as an add-on treatment for depression in adults.

Second try

Proteus’s sensor, the size of a grain of sand, can detect when the pill reaches the patient’s stomach by reacting with stomach acid, whereupon it sends a signal to a patch worn on the chest. This relays the information to an app on the patient’s phone as well as to their doctor and, if they so wish, family members or other caregivers. The patch can also track the patient’s movement as an indicator of their overall health, and they can use the app to report their mood and sleep quality.

The product was first submitted to the FDA two years ago (FDA nod for first sensor-drug would be a milestone for Proteus, September 11, 2015). But the agency issued a complete response letter in April 2016, saying it needed more information on the combo’s performance under real-life conditions, data on use-related risks and evidence that patients could use the device safely and effectively.

Otsuka and Proteus resubmitted in May this year, and this time the FDA said yes, albeit with a label that specifically states that the product has not been shown to improve patients' adherence to their treatment regimen.


Proving this will be key to Otsuka and Proteus being able to make a cost-effectiveness case for the pill-sensor combo. Poor adherence to medication is a major consideration for healthcare systems since care becomes more expensive as non-adherent patients’ conditions deteriorate. To gain traction suitable pricing will be vital; this has yet to be disclosed.

If cost-effectiveness can be proven Proteus will be in an enviable position. The ability to track patient compliance with many types of drugs would benefit healthcare systems enormously.

Therapies for Alzheimer’s disease or other disorders that affect memory or cognitive function are obvious candidates, as are antibiotics. It could even be incorporated into opioid painkillers, not to monitor adherence so much as overuse.

So approval is just the start, particularly for Proteus. The main goal now has to be proving a link between use of the sensor and improved compliance, and the company has trials ongoing in several conditions looking at adherance rates.

The California group has received over $350m in venture funding since 2004 and its investors will be hungry for a return. The company says it is is already talking to potential partners interested in new combo products. The technology’s potential is enormous, but realising it depends on getting the first product right.

To contact the writer of this story email Elizabeth Cairns in London at [email protected] or follow @LizVantage on Twitter

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