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hearing voices, believing other people are reading their minds or controlling their thoughts, making them suspicious or withdrawn.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



14 November 2017
The Taliban attacked a checkpoint in Afghanistan: eight victims
The militants used sophisticated night-vision goggles to attack the officers in their beds, according to The New York Times . The fighters hid in a cemetery near the village of Pule Regi and watched the police officers with the night-vision goggles.

14 November 2017
IOS 11.2 Will Explain Control Center's WiFi/Bluetooth Toggles
Apple's developers are seemingly testing whether that element of the design needs a formal fix, per MacRumors . While somewhat understandable, users argue that they should have at least been informed of that fact.

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
Raiders to break ground on Las Vegas stadium
The Raiders officially broke ground at the Russell Road site in Las Vegas for the team's new stadium, slated to open in 2020. Former Raiders players and at least three National Football League team owners are expected to attend the groundbreaking.

14 November 2017
Hariri says he will return to Lebanon soon, leaves doubt about resignation
Hariri's office said he met several diplomats in Riyadh on Monday including the British and German ambassadors. The Saudi-led coalition, which includes the UAE, is fighting the Houthis on behalf of the Yemeni government.

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
Man shot by police in the Bronx
Police responded to a report of an assault inside the shelter on Hughes 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).