FDA Approves Pill With Sensor Abilify MyCite; Otsuka Stock Up

FDA Approves Pill With Sensor Abilify MyCite; Otsuka Stock Up

FDA Approves Pill With Sensor Abilify MyCite; Otsuka Stock Up

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

The newly approved pill is called Abilify MyCite, and it's created to sense when patients have taken their dose of Abilify, an antipsychotic that is commonly used to treat mental disorders such as schizophrenia and bipolar disorder. At first techno-blush, concerns about Big Brother tapping one's body fall to the wayside; patients can voluntarily give access to the information gathered by the sensor to their doctor and designated family members or caretakers.

There are a couple of caveats, though.

Abilify MyCite's tracking system is centred around a tiny ingestible sensor about the size of a grain of sand, called an Ingestible Event Marker (IEM), made from safe levels of copper, magnesium and silicon. Coming into contact with fluids in the stomach, the sensor is activated and communicates this to the MyCite Patch.

Take for instance the smart pill that the U.S. Food and Drug Administration (FDA) just approved, which is meant to monitor if patients are sticking to their medication schedule.

Before prescribing the new pill and tracking system, doctors should ensure that their patients are capable of and dedicated to using the system, says the FDA.

Would you be happy taking a tablet that beams information to your smartphone?

"The time is right for the category of digital medicines to be available to appropriate patients with serious mental illness", said Andrew Thompson, president and chief executive of Proteus Digital Health.

People who meet the criteria for Abilify MyCite can decide, along with their doctors and caregivers, whether this type of medication monitoring might help them manage their disease. But, the app that works with the digital drug system allows patients to revoke access to data at any time.

The approval also opens the door for pills that are used for other conditions beyond mental health to be digitized.

While patients could choose not to take the pill, its approval could raise questions about privacy and whether some patients might feel pushed into taking the digital pill.

But people with schizophrenia and bipolar disorder can also have impaired executive functions, including short-term memory, and may forget to take-or forget if they've taken-their medication for the day. For this digital pill combination, it partnered with Japanese drug maker Otsuka Pharmaceutical, which makes Abilify. Quoted in the New York Times, Harvard Medical School instructor Ameet Sarpatwari, MD, said a digital pill "has the potential to improve public health", but added that, "if used improperly, it could foster more mistrust instead of trust". "[But] if used improperly, it could foster more mistrust instead of trust".

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