techkenyot.com
techkenyot.com January 17, 2019


MA pols wary of new Rx opioid

07 November 2018, 10:29 | Silvia Roy

FDA OKs powerful opioid pill as alternative to IV painkiller

FDA OKs powerful opioid pill as alternative to IV painkiller

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

In a highly controversial move, the Food and Drug Administration approved an especially powerful opioid painkiller despite criticism that the medicine could be a "danger" to public health.

But critics of the drug and its potency - it's 10 times stronger than fentanyl - are tired that such a pill could add to the country's already alarming opioid epidemic.

Dsuvia is a sublingual (meaning it is taken under the tongue) form of sufentanil (a synthetic opioid) that's delivered through a disposable, pre-filled, single-dose applicator, the FDA says.

7-Eleven Launching Customer Self-Checkout 11/05/2018
How can we make every 7-Eleven a breeze? Once a customer is near or in a pilot store, the option to "start scanning" will appear. The app also lists available discounts, loyalty program rewards and promotional pricing.

Critics blasted the agency for bringing a new opioid to market as the nation faces increasing opioid overdose deaths in what many call a crisis.

Critics are blasting the FDA for approving Dsuvia as the country faces increasing opioid overdose deaths.

But Gottlieb stressed Friday that his agency has placed very tight restrictions on Dsuvia. "It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group, said in a statement.

More: The opioid crisis hits home. It will not be available at your local pharmacy and is designed only for use in a "certified medically-supervised healthcare settings".

Jets' Sam Darnold on struggles: 'Quite frankly, I'm just playing stupid'
The New York Jets stumbled their third straight loss in Week 9 after a disappointing 13-6 loss on the road to the Miami Dolphins . Coach Todd Bowles after the game said Long had not been benched for performance issues but because he reinjured the finger.

"Because of the risks of addiction, abuse and misuse with opioids; Dsuvia is also to be reserved for use in patients for whom alternative pain treatment options have not been tolerated, or are not expected to be tolerated, where existing treatment options have not provided adequate analgesia, or where these alternatives are not expected to provide adequate analgesia", according to a statement from Gottlieb about the drug's approval.

Gottlieb also points out in his statement that it can help in special circumstances in which a patient may not be able to swallow, adding that there could be potential uses on the battlefield.

The pills contain sufentanil, a chemical cousin of the opioid fentanyl. But Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky who chairs the committee, then took the rare step of publicly condemning that decision and urging the FDA to reject the drug.

AcelRx already has approval for 15- and 30-microgram versions of the drug in Europe.

Gov: GOP Rep. Ron DeSantis is elected governor of Florida
According to NBC News, Republican Governor Rick Scott led Democratic Senator Bill Nelson by less than half a percentage point. Democratic Party officials, who have accused Kemp of trying to suppress the minority vote, quickly denied the charge.

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. The Defense Department paid for R&D activities for Dsuvia through a 2015 contract in search for a replacement to using morphine injections, according to AcelRx's Securities and Exchange Commission filings.



Other News

Trending Now

Duke underdogs vs. Kentucky in Champions Classic
Barrett had a game-high 33 points in 32 minutes on 13-of-26 shooting from the field, including a 3-of-7 mark from downtown. While he did finish with 22 points and seven rebounds, most of his buckets came once the outcome was already decided.

"Stand Up To PM, Protect Nation": Rahul Gandhi's Message To Urjit Patel
Previous governors too had occasionally pointed out the government's overreach, when it came to the functionality of RBI. The RBI did not immediately respond to a request for comment.

Republican Ron DeSantis Elected Florida Governor, Beats Andrew Gillum
Blaise Ingoglia, who chairs the state's Republican Party, said it's proof yet again that the GOP in Florida is better organized. The race was the third office he's sought in two years: his re-election, Senate and governor.

Fans react to Marcus Rashford's late victor
In the second half, I could understand some of the frustration because we produced some incredible chances and we didn't score. We don't know, a muscle problem , and we have to wait a little bit". "So I think he was really good for us".

Assassin's Creed Odyssey Level Cap is Being Increased
The self-contained story Divine Intervention will center around a "mysterious woman" who will test players with divine trials. The studio has laid out its plans for November, and they include lots of new content along with quality-of-life tweaks.

Pediatricians: Spanking Children As Punishment Causes Harm
He added, "The loving relationship between a child and their parents is the most important relationship that there is". Teenagers in countries with a full corporal punishment ban are less likely to engage in fistfights.

Northern Districts duo smash world record 43 from an over
Ludick finally got the next ball right in the blockhole which was only taken for a single by Hampton. In all, the pair added 178 for the sixth wicket after coming together at 95 for 5.

New England pizza, sandwich chain closes dozens of locations | AP business
The company hasn't provided a full list of the closures and a company spokeswoman didn't immediately comment. The company said it closed 95 underperforming stores on Sunday to begin the process of restructuring.

States Legalize Marijuana For Recreational Or Medical Use
In Missouri, voters will be asked to chose between three separate proposals legalizing medical marijuana to varying degrees. To learn more about the proposal and the effects of legalizing marijuana, read Mark Peterson's in-depth report .

Joshua: Usyk is a ’perfect’ fighter
But that, I think, is sometimes the right time - is to say that I'm not on the down slide, a bit like [Carl] Froch. He is a good boxer, had good movement and he can put pressure on.