Health Care

FDA approves first digital drug to track if you take your meds

FDA approves first digital drug to track if you take your meds”

Following the doctor's orders might soon be unavoidable advice.

The U.S. Food and Drug Administration approved a joint application by Proteus Digital Health and Otsuka Pharmaceutical for a medication monitoring tool for patients taking Otsuka's drug Abilify.

The drug is approved for the treatment of bipolar I disorder characterized by the occurrence of at least one manic or mixed episode, schizophrenia, and add-on treatment for depression in adults. If a patient opts to allow it, the patient's caregivers and doctor can access the data online, too. But the new product will also be labeled with a caveat: There's no evidence that the technology can help patients take their medication as prescribed.

"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients", said Mitchell Mathis, director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. It noted that the ability of the sensors to track the patient's compliance with their treatment regimen "has not been shown".

Schizophrenia is a chronic, severe and disabling brain disorder, and its symptoms include hearing voices, believing other people are reading their minds or controlling their thoughts, making them suspicious or withdrawn.

Aripiprazole is approved with a boxed warning concerning an increased risk of death when used as a treatment for elderly patients with dementia-related psychosis. Additionally, the medication has been associated with increased suicidal thoughts and behavior in children, adolescents, and young adults taking antidepressants. The sensor technology and patch are made by Proteus Digital Health.

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.

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. The common adverse events associated with the sensor were related to the patch, and were predominantly skin irritation. In September, the FDA approved the first mobile app to treat certain substance use disorders, developed by the Boston company Pear Therapeutics. Monday's hard-won approval could come as a big boost for Otsuka, which had lost market share after Abilify went generic but will now have a way to make the product stand out.



Like this

Latest


14 November 2017
Boston Celtics: Kyrie Irving questionable on the road in Brooklyn
Without Irving, the Celtics extended their winning streak to 12 games with a win against the Toronto Raptors . When he does he return, Irving will be sporting a new face mask, but he won't let that slow him down.

14 November 2017
TJ McDonald and Ted Larsen will start for Dolphins vs. Panthers
Although the Dolphins did return with one touchdown, Carolina still led by 24 points just before the fourth at 38-14. The Dolphins retaliated, scoring a touchdown, but the Panthers didn't let them get much further.

14 November 2017
Amber Alert issued for 3-year-old San Antonio boy
Both SAPD's Eagle helicopter and the Department of Public Safety's helicopter are in the air searching for the auto and child. Whey they returned, police say her vehicle was gone with her child sleeping inside.

14 November 2017
Doctor from Springfield Twp. shot, killed outside Massillon hospital
Police Chief Keith Moser said the shooting is being investigated as an attempted murder-suicide, the Canton Repository reported. He then walked to his vehicle , which was parked behind Seese's and shot himself, the television station said.

14 November 2017
Arsenal boss Wenger: Man City aren't unstoppable
Arsenal manager Arsene Wenger has insisted that Manchester City will be beaten this season. "Maybe, maybe not. Wenger is still frustrated by the decisions made in that game, but is convinced City are not unbeatable.

14 November 2017
Why to Keeping Eye on 3M Company (MMM), JPMorgan Chase & Co. (JPM)?
Several other hedge funds also recently made changes to their positions in JPM. 32 funds opened positions while 85 raised stakes. Over the last five days, shares have faced -3.85% losses and now is up 7.6% since hitting its 200-day moving average of $91.55.

14 November 2017
Giants owner John Mara vows support for coach Ben McAdoo
The Giants reached rock bottom on Sunday with their 31-21 loss to the previously winless San Francisco 49ers . The coach was asked if having ownership on his side will help him prepare the team and get wins this year.

14 November 2017
Is Whole Foods Market Becoming the Next Target?
According to the tech giant, the Amazon staffed Pop-Up's will allow customers to test out devices before purchase as well as learn about other Amazon services.

14 November 2017
Man shot by police in the Bronx
Police responded to a report of an assault inside the shelter on Hughes Ave.in the Tremont section around 7:30 p.m. They found two women stabbed, and then the police shot and killed the man, the law enforcement official said.

14 November 2017
Findlay Park Partners LLP Has $245.94 Million Stake in Mastercard Incorporated (MA)
The Firm operates through four divisions, namely, Post Consumer Brands, Michael Foods Group, Active Nutrition and Private Brands. The Reilly Financial Advisors Llc holds 98,338 shares with $11.94 million value, down from 106,798 last quarter. (NYSE:CAT).



Recommended