"The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers", added Mitchell Mathis, M.D. Psychiatric Products Division director for the Center for Drug Evaluation and Research at the FDA.
The FDA approved Abilify in 2002 to treat schizophrenia, which affects about one percent of the U.S. population.
The drug-device combination is approved for several of the same indications as regular Abilify, including schizophrenia, add-on therapy for depression in adults, and. acute treatment of manic and mixed episodes associated with bipolar I disorder.
The new product, which will be sold as Abilify MyCite, can be swallowed just like any other pill. The sensor that is used along with the medication was first cleared for use by the FDA in 2012; however, the approval of the pill and the sensor together represents a milestone for the FDA. Otsuka collaborated with Proteus Digital Health, the Silicon Valley company that designed the futuristic sensor technology. The pill is embedded with a tiny sensor about the size of a grain of sand that lets doctors know if and when a patient has taken their medication.
The system sends a message from the pill's sensor to a wearable patch. That information produced can also be accessed by caregivers and physicians through a web-based portal so they are able to keep track of the patients as well. "Abilify MyCite should not be used to track drug ingestion in "real-time" or during an emergency because detection may be delayed or may not occur".
The FDA says that the ability to track the consumption of prescribed medicines for mental illness may be useful "for some patients", although the ability of digital pills to improve patient compliance has not been proven. It comes as well with a Boxed Warning to alert healthcare professionals to the effects of antipsychotic drugs on elderly patients diagnosed with psychosis related to dementia, citing higher death risk. The label also warns of increased risk of suicidal thinking and behavior among children, teens and young adults.
OnePlus phones include an easily exploitable backdoor
Dubbed " EngineerMode " the tool has been designed as an easy way for phone makers to test the hardware on their devices. Once the app was decompiled, a password was still needed for the app so that it would give root access to devices.
Forecast: Chilly Week Ahead With Some Rain
We will see increasing clouds through the day and some showers could come through late in the evening to the overnight hours. This afternoon clouds will stick around for much of the day with highs struggling this afternoon hitting the mid 40s.
League victor Liam Miller, 36, fighting cancer
Ex-England striker Chris Sutton said: "All thoughts and prayers go out to my old teammate Liam Miller tonight". All thoughts go out to him and his family, I think he has three children as well.
Carbon emissions back on the rise
US emissions are expected to decline by.4 percent, compared to a typical decline in the country of about 1.2 percent per year. China's emissions are projected to grow by 3.5% (0.7% to 5.4%), driven by a rise in coal consumption (GDP up 6.8%).