Following the doctor's orders might soon be unavoidable advice.
The U.S. Food and Drug Administration said on Monday that it had approved Otsuka Pharmaceutical Co Ltd's Abilify MyCite, the first drug with a digital ingestion tracking system to be approved in the United States. The product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults.
The system works by sending a message from the pill's sensor to a wearable patch. If a patient opts to allow it, the patient's caregivers and doctor can access the data online, too.
Called Abilify, the purely chemical version of the drug actually received FDA approval over a decade ago to treat patients with schizophrenia and bipolar disorders. Abilify was approved ten years earlier. Patients should be monitored for worsening and emergence of suicidal thoughts and actions. Abilify MyCite must be dispensed with a patient Medication Guide that describes important information about the drug's uses and risks.
In the clinical trials for Abilify, the most common side effects reported by adults taking Abilify 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 placement may occur in some patients.
Abilify was first approved by the FDA in 2002 to treat schizophrenia.
The sensor is the size of a grain of sand and made from magnesium and copper, according to Proteus Digital Health, the maker of the technology.
Nevertheless, the regulatory approval is a big win for Proteus, which has been promoting its self-tracking pill technology as a way to help patients take their medicine as prescribed. However, Abilify MyCite's own prescription labeling says it still hasn't been shown the drug improves "patient compliance" with their treatment, according to the FDA.