Wednesday, 21 November, 2018

FDA approves opioid stronger than fentanyl

FDA approves new opioid The FDA just approved an opioid painkiller 10 times more powerful than fentanyl
Samantha Long | 07 November, 2018, 22:30

What makes this particular approval so interesting is that the drug has many outspoken critics.

A tiny pill more potent than 1,000 times the strength of morphine has been approved for use by the Food and Drug Administration.

The decision has met a lot of criticism because the opioid is 5-10 times more potent than pharmaceutical fentanyl.

Gottlieb said Dsuvia, which is administered under the tongue through a disposable, pre-filled, single-dose applicator, "is restricted to use in certified, medically supervised health care settings - such as hospitals, surgical centers and emergency departments - for administration by a health care professional".

Critics, including the head of the FDA advisory committee that reviews pain-relieving products, are anxious about putting such a potent and addictive medication on the market in the midst of the U.S.'s opioid crisis. Approval of the drug was highly criticized; Raeford Brown, MD, chair of the FDA's Anesthetic and Analgesic Drug Products Committee, urged the FDA not to approve Dsuvia. In a lengthy statement, Scott Gottlieb, FDA Commissioner, said there will be "very tight restrictions" placed on its distribution and it is intended only for supervised settings like hospitals.

"It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", Sidney Wolfe, founder of Public Citizen's Health Research Group, said in a statement.

7-Eleven cashierless checkout testing begins in 14 Dallas stores
The new payment feature is added to the 7Rewards loyalty program, which lets customers earn and redeem reward points and coupons. The new Scan & Pay feature will be available to customers at 14 7-Eleven stores in Dallas, Texas, according to Digiday .

Sanjay Gupta that opioids are the biggest crisis facing the nation, a crisis fueled by overprescribing. Preliminary figures show more than 72,000 people died in 2017 from drug overdoses across the country.

"To address concerns about the potential risks associated with Dsuvia, this product will have strong limitations on its use", Gottlieb said.

The statement noted the benefit the drug could have for soldiers injured on the battlefield.

Brown, four U.S. Senators and the advocacy group Public Citizen have predicted that Dsuvia will be diverted to illicit use and cause more opioid overdose deaths. The drug, Dsuvia, is a tablet form of sufentanil, a synthetic opioid that has been used intravenously and in epidurals since the 1980s. For this reason, the Department of Defense (DoD) worked closely with the sponsor on the development of this new medicine. The study demonstrated that patients receiving the drug experienced significantly greater pain reduction versus placebo over the first 12 hours post-treatment.

AcelRx already has approval for 15- and 30-microgram versions of the drug in Europe. Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients.

The manufacturer, a California company called AcelRx, will market the drug beginning in early 2019 under the name Dsuvia, at a wholesale price of $50 to $60 per dose.

Recommended

Ron DeSantis Elected Florida Governor, Andrew Gillum Concedes Ron DeSantis Elected Florida Governor, Andrew Gillum Concedes The stark differences between the two candidates and the negative nature of the race were crystallized in two vitriolic debates. During the campaign, Gillum repeatedly launched accusations of racism against DeSantis , which DeSantis firmly denied.

Carl Froch has predicted the outcome of Tony Bellew vs Oleksandr Usyk Carl Froch has predicted the outcome of Tony Bellew vs Oleksandr Usyk Even though Bellew eventually won, it shows you that he can be hurt, he can be dropped by a southpaw . It would be a shame to see Bellew, after everything he's done in the last couple of years, do that.

Ariana Grande performs 'Thank U, Next' in a wedding dress What we love most about this video is that Ariana could have totally redone the whole thing, but chose not to. GC Images via Getty Images Ariana Grande and Mac Miller attend an Oscars after-party in 2016.

Trump BLOWS UP at Jim Acosta: 'You are a rude, awful person' Trump BLOWS UP at Jim Acosta: 'You are a rude, awful  person' A digest of the top political stories from the Globe, sent to your inbox Monday-Friday. You know why we need the people?" "Do you think they were actors? You run CNN .

6 arrested in suspected plot to attack French President Emmanuel Macron 6 arrested in suspected plot to attack French President Emmanuel Macron Europe and its security", he said, referring to Trump's recent decision to quit the Intermediate-Range Nuclear Forces treaty. The French president recalled that the European Union is a unique project of peace and prosperity in the world's history.

Saints, Dez Bryant negotiating deal after workout Saints, Dez Bryant negotiating deal after workout Third-round rookie Tre'Quan Smith has started four games this season, tallying 214 yards and three touchdowns through eight games. Bryant visited New Orleans on Monday, working out with fellow wideouts Brandon Marshall and Kamar Aiken .

Iran sanctions: US exempts India from some restrictions for Chabahar port Iran sanctions: US exempts India from some restrictions for Chabahar port In the US , industry data were said to show that nationwide crude inventories rose last week, expanding by 7.83 million barrels. Sanctions targeting Iran's oil, banking and transport sectors came into effect on Monday.

Prince Charles talks about 'horror' of slave trade Prince Charles talks about 'horror' of slave trade Prince Charles acknowledged the "abject horror" of Britain's role in slavery in a speech at a Young Entrepreneurs Event in Ghana yesterday.

Fantastic freshmen help No. 4 Duke blow out No. 2 Kentucky Fantastic freshmen help No. 4 Duke blow out No. 2 Kentucky The game marked the first time Kentucky faced a ranked opponent in a season opener since a 79-71 overtime loss to Clemson in 1995. Kentucky will have to find a way to get him more involved in the offense moving forward, as he attempted just eight total shots.

Uganda starts Ebola vaccination for high-risk health workers Uganda starts Ebola vaccination for high-risk health workers The ongoing Uganda vaccinations targeting frontline health workers will be carried out in five districts along the border with Congo.

Alexandria Ocasio-Cortez elected as youngest woman in US Congress Alexandria Ocasio-Cortez elected as youngest woman in US Congress She calls herself a "Democratic socialist" and supports a national US$15 minimum wage and universal health care coverage. House of Representatives with a resounding victory in Tuesday's general election, Yahoo News reported .

Brothel owner Dennis Hof wins seat in Nevada despite being dead Brothel owner Dennis Hof wins seat in Nevada despite being dead Hof, who presented himself as an American pimp, was a strip-club owner who ran multiple brothels. Hof owned a handful of brothels in Nevada, the only state that allows them to legally operate.

Rockstar Working on Fix for Red Dead Redemption 2 Camp Glitch Rockstar Working on Fix for Red Dead Redemption 2 Camp Glitch We are aware of the issue and are now working on a fix to be included in an upcoming Title Update. I am, unfortunately, one of the affected, and I only discovered as much far too late.

'Defensively awful': Jose Mourinho relief after Manchester United late show 'Defensively awful': Jose Mourinho relief after Manchester United late show Jose Mourinho recognised Manchester United had been "very lucky" to win 2-1 at Bournemouth after an "awful" first-half display. Mourinho was infuriated with a sloppy first half, saying: "It was the whole first half".

New cricket world record set by Kiwi batsmen New cricket world record set by Kiwi batsmen Brett Hampton missed his maiden List A century by just five runs, while Joe Carter went on to complete his ton. It was the Kiwi pair of Joe Carter and Brett Hampton who did it as they were aided with no-balls.