The FDA approves the first digital pill available in the US

Pill prescribed patients will soon have a new method to remember to take their medication on time.

The FDA has approved Abilify MyCite, the first digital pill that will be available in the US. Developed to treat schizophrenia, bipolar disorder, and depression, the Abilify MyCite pill will be outfitted with an ingestible sensor that will work in tandem with a patch worn by the patient on the left rib cage.

class="aligncenter" src="http://uploads.dancingastronaut.com/2017/11/Screen-Shot-2017-11-14-at-10.21.46-AM.png" alt="Pill" />

Photo Credit: The Verge

The patch will transfer medication data to a smartphone app that may be accessed not only by the patient, but by the patient’s doctor, and other parties specifically authorized by the patient. The patient’s ability to upload medication information to a database that can be accessed by a doctor seeks to effectively streamline the prescriptive feedback cycle that engages both patient and physician, while providing a solution to the widespread problem of patients not taking their medication correctly. The IMS Institute approximates that improper and/or unnecessary medicine use cost US healthcare more than $200-billion-dollars back in 2012.

Collaboratively developed by Otsuka and Proteus Digital Health, Abilify MyCite contains a small sensor, comparable in size to a grain of sand. Silicon, copper, and magnesium comprise the sensor. The sensor works by sending an electrical signal when it comes into contact with stomach acid. The patch worn by the patient responds to the signal transmitted by the sensor minutes thereafter, registering the pill’s ingestion, and accordingly forwarding confirmation of the pill’s consumption to the smartphone app designed to communicate with the patch via Bluetooth. The patient can grant app access to up to four people, not including the patient’s doctor. The patient may also revoke authorized access at any time. The patch must be replaced each seven-days.

Otsuka has yet to release a projection for the cost of the digitized Abilify MyCite pills, but reportedly plans to coordinate with insurers to cover the costs of the digital pills if insurers demonstrate interest in developing coverage guidelines for the medication.

Otsuka and Proteus Digital Health’s creation of the first FDA approved digital pill is expected to inspire a demand for the development of other digital pills, despite concerns that a digitized pill could lead to privacy issues. An instructor in medicine at Harvard Medical School, Armeet Sarpatwari underscored the possibility for abuse of the digitized Abilify system, where physicians, supplied with confirmations as to whether the patient has taken the prescribed medication in question, might “punish” patients that do not follow prescriptive directions. Sarpatwari notes that Abilify MyCite “has the potential to improve public health. [But] if used improperly, it could foster more mistrust instead of trust.”

The digitized Abilify MyCite pill is able to register a patient’s activity levels, sleeping patterns, steps taken, general activity, and heart rate, marking a multifunctional capacity that has the power to dramatically alter the contemporary science of pill prescription, ingestion, and the tracking thereof.

H/T: href="https://www.theverge.com/2017/11/14/16648166/fda-digital-pill-abilify-otsuka-proteus" >The Verge

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