First ever 'digital pill' submitted to FDA

Pharmaceutical company Otsuka and medical technology firm Proteus Digital Health have had their filing for the world's first 'digital pill' accepted by the FDA.

The new product combines Otsuka's existing schizophrenia drug Abilify (aripiprazole) with an ingestible sensor embedded into the tablet, and is aimed at help track medicines compliance as well as physiological response to the drug.

Poor compliance with medicines is a huge problem, with up to 50 per cent of patients with chronic diseases in developed countries not taking their treatments as prescribed.

The data gathered from the pill is communicated to the patient via a wearable sensor patch and a medical software application. Patients then give their consent to pass this information on to their consent of their doctor and caregivers.

Patients can use the application on their mobile phone or device, while healthcare professionals and caregivers view the data using secure web portals.

The filing is a landmark in so-called 'digital medicine,' the convergence of new technology with drugs. The hope is that the device can help improve medication adherence and decision-making in healthcare, but must first be approved as safe and effective by the US regulator.

The drug has been classified as a drug-device combination by the FDA. Proteus' ingestible sensor and wearable patch have already been cleared for use as a device in the US and Europe, but now must gain approval via a New Drug Application (NDA) combining it with the active drug.

"Today, patients suffering from severe mental illnesses struggle with adhering to or communicating with their healthcare teams about their medication regimen, which can greatly impact outcomes and disease progression," said William H. Carson, M.D., president and chief executive of Otsuka Pharmaceutical Development & Commercialisation. "We believe this new Digital Medicine could revolutionise the way adherence is measured and fulfil a serious unmet medical need in this population. We look forward to continuing working with the FDA throughout the NDA review."

Once swallowed by the patient, the ingestible sensor sends a signal to the wearable Proteus patch after it reaches the stomach. The patch records and time-stamps data from the sensor, and also collects other patient metrics, including rest, body angle and activity patterns, which should help provide data on the patient's well-being.

"Digital Medicines have the potential to move healthcare beyond the proven efficacy of a medicine to understand the real world effectiveness of a therapy for each individual," said Andrew Thompson, president and chief executive of Proteus Digital Health. "This means that medicines could be tailored to each of us to reflect our unique medication-taking patterns, lifestyle and daily health choices."

In the UK, Proteus has been working closely with the national health service and the government to investigate the benefits of the technology for patients and healthcare systems. Several regional Academic Health Science Networks (AHSNs) in England have been working with the company since 2014 to look at its practical use in frontline healthcare and help promote innovation on the NHS.