FDA Approves Schizophrenia Medication With Digital Ingestion Sensor

FDA Approves Schizophrenia Medication With Digital Ingestion Sensor

The Food and Drug Administration has approved the first drug in the United States with a digital ingestion tracking system in an unprecedented step to ensure that patients with mental disorders take the medicine prescribed for them.

The system works by sending messages from a pill sensor to a usable patch material, which then transmits the information to the mobile app so that patients can track drug consumption on their smart mobile phone.

The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012.

FDA approval of Abilify MyCite was granted to Otsuka Pharmaceutical Co., Ltd.

There were some issues, however, with green-lighting the new digital version as while the system can track doses, it hasn't been shown to improve patient compliance, said the FDA.

Tom Sizemore Was Removed From Film Set For Alleged Sexual Assault
At this point, he allegedly touched her vagina . "I heard something happened on the set but I didn't realize it involved a child". During one setup, which required just the two of them, Robyn Adamson , who portrayed the wife, stood away, near the photographer.

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. Labeling information stresses that it has not been proven if tracking such information improves treatment regimens. And the drug shouldn't be used in an attempt to track "real-time" ingestion, since detection could be delayed, the agency added.

Bipolar disorder, also known as manic-depressive illness, is another brain disorder that causes unusual shifts in mood, energy, activity levels, and the ability to carry out day-to-day tasks. Abilify MyCite also contains a boxed warning about the risks of antipsychotic drugs. 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. This sensor is obviously ingested when the patient takes their medication; it provides data to a related patch the patient wears while taking the meds.

The FDA approval for Abilify MyCite's pill could lead the way for other electronic pills to become available that'll be able to treat other health issues. Skin irritation at the site of the MyCite patch placement may occur in some patients. Otsuka collaborated with Proteus Digital Health, the Silicon Valley company that designed the futuristic sensor technology.

Related Articles