Other news on opioids focuses on the FDA's armed hunt for counterfeit drugs and the continued threat of fentanyl and heroin.
News outlets have decried the approval and emphasized sufentanil's effects as "500 times more powerful than morphine;" however, Pamela Palmer, MD, PhD, chief medical officer of AcelRx Pharmaceuticals, which developed the drug, explained in an interview with Pharmacy Times' sister publication, MD Magazine, that these overstatements are misguided.
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".
Scott Gottlieb was quick to defended the approval in a statement Friday: "The agency is taking new steps to more actively confront this crisis, while also paying careful attention to the needs of patients and physicians managing pain". Acknowledging the criticism, he said he's asked FDA staff to "evaluate a new framework" for the approval of new opioid drugs that will clearly outline how the agency considers benefits and risks. "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. Most of that was the result of a record number of opioid-related deaths.
For Dsuvia specifically, Gottlieb referenced the opioid multiple times as a Pentagon priority, citing its potential use on the battlefield to treat soldiers through its sublingual formulation.
Gottlieb said the drug will carry a boxed warning and won't be available at drugstores for patients to take home.
Marijuana expands into three more states State laws allowing recreational use of marijuana have spread across the United States since Colorado voters approved one in 2012. Impose a 10-ounce limit for marijuana kept at residences and require amounts over 2.5 ounces be secured in locked containers.
79 school pupils abducted in restive anglophone Cameroon Around a fifth of Cameroon's 22 million people are English-speaking - a minority whose presence dates back to the colonial period. A separatist spokesman denied involvement and said government soldiers had staged the kidnapping to discredit the rebels.
May will not agree withdrawal deal with EU "at any cost" The Department of Agriculture, Environment and Rural Development (DAERA) in Northern Ireland also issued advice on its website. It added that "the outcome of any such review could not involve a unilateral decision to end the backstop".
The drug is also only for use by patients who can not tolerate other painkillers, or for whom other painkillers have failed or are expected to fail. According to the administration, prescription opioids were responsible for the most overdose deaths of any illicit drugs since 2001. Alan says the concern around the drug is "valid given the potential for abuse". Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients.
"I am very disappointed with the decision of the agency to approve Dsuvia".
Dsuvia was rejected by an FDA advisory committee in 2017 because the committee wanted more data.
Dsuvia isn't created to be taken by people who haven't taken morphine in the past, Alan says.
"As a single-dose, non-invasive medication with a rapid reduction in pain intensity, DSUVIA represents an important alternative for healthcare providers to offer patients for acute pain management", Dr. David Leiman, clinical assistant of surgery at University of Texas at Houston, said in a statement from AcelRx.
Manchester City chairman Khaldoon Al Mubarak, left, with chief executive Ferran Soriano at Etihad Stadium before a match. The Guardian has not seen or been able to verify the documents Der Spiegel has used in its reporting.
This far, police have been able to identify 14 victims from the nearly 140 body bags of human remains retrieved from the Java Sea. All 189 passengers and crew are feared to have died when the plane crashed shortly after takeoff on October 29.
The Albuquerque Journal includes a logline stating the film " tracks the escape of a kidnapped man and his quest for freedom ". The Journal also reports that the project now has the working title Greenbriar - though that could just be a holding name.
In our in-depth Google Pixel 3 review , we dove into all the reasons these new Pixel phones are the best Pixels yet. The advantage to this? It causes apps to randomly crash, particularly when several are open at once.
Florida also accounts for a quarter of the disenfranchised population in the United States, according to the Sentencing Project . Critics railed against the proposal, saying it would make it far more hard to pass such measures at the state level.
Rick Scott by less than one percentage point, not enough to trigger an automatic recount, with the race still uncalled. Now in another tweet , the President has congratulated Governor Ron DeSantis for being elected Florida Governor.
On Monday the Spice Gir, ls - minus Victoria Beckham - announced they'd be going on tour next year, Bustle reports. Mel B said Posh would be joining the girls for their Wembley date, to which the girls laughed.
They also had a moment of silence for Allen and had the "12 Flag" that's raised before every game lowered to half-staff. Wilson was sacked four times, with several of those his fault for not getting the ball out or trusting the protection.
A White House staff member steps in to try to take the microphone away from CNN's Jim Acosta as he questions U.S. When Acosta repeated his assertion that the caravan is not "an invasion", Trump became enraged. "Sit down.
Gardner deemed it a legitimate tackle as he felt Farrell had made enough of an attempt to wrap his arms in the tackle. A screengrab of Springbok centre Andre Esterhuizen going through some tackling drills.
Red Dead Redemption 2 may not be ideal , but its minor shortcomings are like tiny blemishes on a stunningly handsome face. For all that imagination, the reality of what games offer is usually pretty narrow: kill, or be killed.
I would blame weather for lack of goals, says Alvaro Morata
We thought that it's better to him. "For us, the best work for him is that he will play for 45 or 50 minutes against Bate". Can Chelsea pip Manchester City to the Premier League title? For sure, I always want to score because it is good for me.
Young progressives, VP brother to enter US Congress
Davids is from the Ho-Chunk Nation in Wisconsin and has focused her career on the advancement of Native Americans. Democrats Sharice Davids and Deb Haaland will become the first Native American women elected to Congres.
Nicki Minaj, Little Mix Took The MTV EMAs By Storm
On Sunday, November 4, in Bilbao, Spain , Janet Jackson performed a three-song melody that showed the world that she still has it. At The Disco won Best Alternative , and BTS won Biggest Fans , among others.
TENNESSEE: GOP Marsha Blackburn Wins Senate Seat
Pop superstar Taylor Swift's endorsement of a Democratic Senate candidate in Tennessee didn't amount to much. Bob Corker, were always uneasy with Blackburn's conservative firebrand of politics.