US regulators accept ‘chip in a pill’ application

September 10, 2015 2:45 pm

US regulators accept ‘chip in a pill’ application
By Andrew Ward, Pharmaceuticals Correspondent

Smart medicines that tell doctors when their patients have taken them moved a step closer to reality after a company developing the first “digital pill” had its drug application accepted by US regulators.

The hope is that the pill, produced by Proteus Digital Health, will help ensure patients stick to their prescriptions and so reduce wasteful spending on drugs that are not taken properly.

It could be especially useful in mental illnesses and memory disorders such as schizophrenia and Alzheimer’s where compliance is particularly poor.

The development shows how technology is opening up new frontiers in medical science. Digital health companies attracted $2.8bn of investment in the first half of this year, on top of a record $6.9bn in 2014, according to StartupHealth, a research company that tracks the sector.

California-based Proteus said on Thursday the US Food and Drug Administration had agreed to review its device which is embedded in a schizophrenia medicine made by Otsuka of Japan.

While there is no guarantee of approval, Andrew Thompson, Proteus chief executive, said the FDA’s acceptance of its application was an important milestone. “This is the opening of a new regulatory pathway that allows the pharmaceuticals industry to combine its medical innovation with innovation in software.”

The “smart pill” contains a tiny ingestible sensor that detects when the drug has reached the stomach. It communicates with a wearable patch plastered to the patient’s skin which then transmits the information to a mobile device.

The technology could help patients manage their own treatment and allow carers and medics to monitor them. It could also help cash-strapped health systems ensure that very expensive drugs are not being wasted.

An estimated half of patients in developed countries do not take medicines as prescribed, according to Proteus. In the US alone, this has been estimated to cost the health system up to $300bn in unnecessary costs.

“People are given a bag of pills and told to go away and take them and very often they don’t,” said Mr Thompson, an Englishman and trained engineer who founded privately-owned Proteus in 2001.

Proteus has been working with the FDA for several years to develop a regulatory framework for its products and others like it that follow. The device itself was approved by the FDA in June after dozens of clinical studies involving 800 patients. The combination with Otsuka’s Abilify marks the first approved drug to be filed for review as a digital medicine.

Proteus also has a partnership with Novartis of Switzerland and Mr Thompson says other drugmakers are interested.

Trevor Jones, a UK pharmaceuticals industry veteran and expert in clinical trials, said the technology could be useful during the drug development process. “If you have an elderly person on a clinical trial and you ask her to take a pill for three months you cannot be sure that she has taken it every day. She might not admit it if she hasn’t because she doesn’t want to get in trouble with the doctor.”

The “chip in a pill” can also measure a range of physiological data such as activity patterns, raising the prospect that future digital medicines could provide real-time monitoring of patient health and help assess whether a treatment is working.

Proteus is among a growing wave of start-ups developing digital technology for healthcare and big groups such as Apple and Google are showing interest in the sector. But regulatory hurdles have been a brake on innovation as the FDA and its counterparts elsewhere scramble to develop the expertise needed to assess the safety and efficacy of an new category of medical products.

“The real explosion of innovation in this area is still years away,” said Mr Thompson. “But in 20 years we will make the same distinction between digital drugs and dumb drugs as we make between branded and generic drugs today.”

Copyright The Financial Times Limited 2015.



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