emfizz.com
emfizz.com November 21, 2017


FDA Approves First Digital Tracking Pill In The US

15 November 2017, 12:28 | Todd Saunders

The sensor embedded in the pill sends information to the wearable patch that can be accessed on a phone or tablet. Proteus Digital Health

The sensor embedded in the pill sends information to the wearable patch that can be accessed on a phone or tablet.                  Proteus Digital Health

The US Food and Drug Administration has approved aripiprazole tablets with a sensor to digitally track whether patients have taken their medication (Abilify MyCite).

"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.

Senate Finance Committee begins markup of GOP tax reform bill
Trump praised new bills in the House and Senate, called the Tax Cuts and Jobs Act (TCJA), but suggested a few improvements. Both versions of the tax plan cut the top individual rate, but the Senate version only lowers it to 38.5 percent.


Trump's boss says Israel will continue to destabilize Syria
Israeli Defense Minister Avigdor Lieberman blamed the drone on the Syrian government. Moscow did not immediately provide details on the deal.


Trump asked Xi Jinping to help UCLA basketball players busted shoplifting
LiAngelo Ball's family is in Hong Kong marketing $495 Big Baller Brand shoes, according to a tweet from LaVar Ball . White House Press Secretary Sarah Huckabee Sanders confirmed that Trump and Xi talked about the case.


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.



Other News

Trending Now

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.

Trump Chooses Alex Azar for Health and Human Services Secretary
The drugmaker has drawn criticism from patient advocacy groups for price increases to one of its biggest products: insulin. The White House just named Alex Azar as its new nominee for secretary of the Department of Health and Human Services.

LeBron James: Knicks Made Mistake Passing On Dennis Smith Jr
Some took this as a shot at the player the Knicks did draft, defensive-minded point guard Frank Ntilikina . That's all I was thinking about".

Bella Hadid Gracefully Saved Gigi From Stacking It In Public-Again
When Gigi lost a shoe at Anna Sui's NY fashion show in September, Bella walked by her side during the finale for support. The athlete walked the red carpet at Glamour's Women Of The Year Awards ceremony in Brooklyn, NY on Monday (Nov. 13).

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.

At Least 3 Dead After Shooter Targets Home, School In Northern California
Police fatally shot the attacker after reports of at least seven shooting scenes, including an elementary school, Johnston said. Tehama County Assistant Sheriff Phil Johnston said officers were investigating at least five crime scenes in the area.

Minions studio reportedly creating a Mario movie
The report mentions that Illumination has been in talks with Nintendo about this project for nearly a year. Neither Nintendo nor Illusion is commenting on the apparent leak.

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%).

Zimbabwe Ruling Party Calls Military Chief's Comments Treasonous
Witnesses said one of the tanks, which was pointed in the direction of the capital, had come of its tracks. It is rare for the defence forces to publicly take sides in the affairs of ZANU-PF.