USA regulators approve first digital pill to track patients

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"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients", Mitchell Mathis, M.D., director of the division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research.

A patient ingests the pill, and a sensor inside the pill activates when it reaches the stomach fluids, sending a message to a wearable patch.

In September, the FDA approved the first mobile app to treat certain substance use disorders, developed by the Boston company Pear Therapeutics.

Otsuka Pharmaceutical and Proteus Digital Health, which jointly make Abilify MyCite, said in a news release Monday night that the pill is a logical advance in today's high-tech, connected world.

"Abilify MyCite should not be used to track drug ingestion in "real-time" or 'during an emergency", said the statement, "because detection may be delayed or may not occur".

Providing they sign a consent form, patients can allow up to four other people, including their doctors, caregivers, and family members, to access the data via a web-based portal.

According to the FDA, the Abilify has been approved for the treatment of schizophrenia and bipolar disorder, as well as an add-on treatment for depression.

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Abilify MyCite is not approved for treating patients with dementia-related psychosis. Additionally, the medication has been associated with increased suicidal thoughts and behavior in children, adolescents, and young adults taking antidepressants.

In clinical trials establishing the efficacy of aripiprazole, the most common adverse events were nausea, vomiting, constipation, headache, dizziness, uncontrollable limb and body movements (akathisia), anxiety, insomnia, and restlessness.

Prior to patient use, the FDA urges healthcare providers to ensure that the patient is able to use the system.

Smart pills are a thing and they've come one step closer to entering the mainstream after the FDA approved a pill packed with a digital sensor for the first time in the US. By allowing physicians to track a patient's use, Nath said he hopes to avert "dramatic and immediate health-care crises, such as for schizophrenia patients where missing medicines can result in a psychotic break which will land them in an ER".

"The time is right for the category of Digital Medicines to be available to appropriate patients with serious mental illness", said Proteus CEO Andrew Thompson.

"This approval marks a potentially transformative juncture in our more than 25 years of experience in the field of mental health therapies", said Tatsuo Higuchi, representative director and president for Otsuka Pharmaceuticals.

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