FDA Reviews First NDA for “Digital” Medicine Product


FDA has accepted for review the first NDA for a “digital” medicine product. The product, which is produced by Otsuka Pharmaceutical Co., Ltd. and Proteus Digital Health, is the first-ever medication of its kind. This unique product is a combination product consisting of Abilify, an FDA-approved medication, in combination with the Proteus ingestible sensor, a sensor that is embedded into the tablet to measure actual medication-taking patterns and physiologic response. According to a Business Wire press release, the information is gathered and then communicated to the patient and to the patient’s physician and/or caregiver (with consent of the patient).

Abilify was initially approved by FDA in 2002 for use in the treatment of schizophrenia. Since then, the product’s oral indication has been expanded to include:

  • Acute treatment of manic and mixed episodes associated with bipolar I,
  • Adjunctive treatment of major depressive disorder;
  • Irritability associated with autistic disorder; and
  • Treatment of Tourette’s disorder.

In addition to the oral formulation, Abilify is also available in an injectable formulation, which is indicated for the treatment of agitation associated with schizophrenia or bipolar mania.

The Proteus ingestible sensor, cleared by FDA for marketing as a medical device in 2013, is part of the Proteus digital health feedback system, and is linked to a wireless skin patch which the sensor uses to communicate. It is also able to record heart rate, temperature, activity, and even rest patterns. The way it works is through the reaction two conduct materials with the stomach acid, which powers the sensor for a short amount of time. The corresponding patch is powered by batteries and lasts about seven day, at which time it is then replaced.

When ingested, the sensor works by sending a signal to the patch once it reaches the stomach. The patch records the time and other available information which can be viewed by the patient on their cell phone via a specified app. At the same time, the information is then available to the patient’s physician(s) and/or caregiver(s).

By combining the sensor with Abilify, it will become possible to track and measure how well patients are following their treatment for various conditions, including: schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and as adjunctive therapy for the treatment of major depressive disorder in adults.

While there are sure to be varying opinions on the product, one thing that cannot be argued is the fact that it is extremely novel and the first of its kind. It will be interesting to follow the product through the NDA review process to see how it plays out.