FDA approves first digital pill

Abilify MyCite (aripiprazole) tablets have an ingestible sensor embedded in the pill and are available for the treatment of patients with schizophrenia, episodes of bipolar disorder or as an additional treatment for adults with depression.

Digital pill

The first pill which can be digitally tracked as it makes its way through the body has been approved for use by the US safety drugs watchdog, the Food and Drug Administration (FDA).

Abilify MyCite (aripiprazole) tablets have an ingestible sensor embedded in the pill and are available for the treatment of patients with schizophrenia, episodes of bipolar disorder or as an additional treatment for adults with depression.

When a patient takes the pill, a message is sent from its sensor to a patch worn on the arm. The data is forwarded to an app on the patient’s smart phone and they are able to track the ingestion of the medicine.

Patients can also share the data with their carers or doctor, following consent, via a web-based portal. 

Announcing the decision, Mitchell Mathis, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research said: “Being able to track ingestion of medications prescribed for mental illness may be useful for some patients.”

The decision was welcomed by John Kane, chair of psychiatry at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in New York. 

He said: “For the first time in my years of experience as a psychiatrist, there is an innovative way to provide individuals with serious mental illness, and selected members of their families and care teams, with information on objective medication-taking patterns to help inform the patient’s illness management and personalised treatment plan.”

Tatsuo Higuchi, president and representative director of Otsuka Pharmaceuticals, described the approval as “a potentially transformative juncture in our more than 25 years of experience in the field of mental health therapies”. 

The product is being rolled out to a limited number of health providers and selected patients in the US before it is made more widely available.

The FDA said that the product has not been shown to improve patient compliance with their treatment regimen. It also advised that it should not be relied on to track drug ingestion in “real time” or in an emergency because “detection may be delayed or may not occur.” 

The product comes with a boxed warning and is not recommended for elderly patients with dementia-related psychosis who are at increased risk of death. Its safety and effectiveness has not been established in paediatric patients.

The FDA said health professionals should monitor children, adolescents and young adults taking antidepressants for increased risk of suicidal thinking and behaviour.

In clinical trials, the most common side effects reported by adults were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness. Skin irritation at the site of the MyCite patch is possible in some patients.

Abilify was first approved by the FDA in 2002 for the treatment of patients with schizophrenia. A decade later, it gave a marketing approval for the digital sensor used in Abilify MyCite.

The European Medicines Agency said there is no “pending application” to introduce Abilify MyCite in the European Union.

However, it said it has considered the potential use of this kind of digital technology.

A spokesperson explained : “The EMA’s Committee for Medicinal Products for Human Use agreed in considering the use of this technology as a qualified method for measuring adherence in clinical trials.

“This type of opinion aims to support the use of innovative methods during the development of medicines and ultimately facilitate both medicine development and the subsequent assessment of a marketing authorisation application based on the use of such innovative methods.”

Abilify MyCite is marketed by Otsuka Pharmaceuticals. The sensor technology and patch are made by Proteus Digital Health.

Last updated
The Pharmaceutical Journal, PJ, November 2017, Vol 299, No 7907;299(7907):DOI:10.1211/PJ.2017.20203940

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