FDA approves highly effective new opioid regardless of ongoing epidemic

FDA OKs powerful opioid pill as alternative to IV painkiller

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.

Related:

Comments

Latest news

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.

Musk showed nearly complete sverhskorostey tunnel under Los Angeles
Similarly, in May, Musk had made apparent the challenges Tesla was facing when it came to executing the company's plans for India. Still, in his most recent tweet , Musk outlined the company's long-term vision for expanding beyond its current biggest markets.

Chris Watts Reaches Plea Deal In Murder Case To Avoid Death Penalty
Under Colorado law, a first-degree murder conviction carries a mandatory life sentence without the possibility of parole. The Colorado Bureau of Investigations later said Shanann Watts and the girls were murdered inside their home.

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.

Nadal's hard-court woes continue with ATP Finals withdrawal
The second racket of the world Rafael Nadal due to injury will not play Final of the ATP tournament. Furthermore, Djokovic enjoys a lifetime 25-22 record over Federer and 27-25 against Nadal .

PTV 'accidentally' trolls Imran Khan with an offensive typo
The statement further read that Foreign Minister Shah Mehmood Qureshi would soon meet with the sister of Dr. "Government of Pakistan has been raising the issue of Dr.

Ron DeSantis Elected Florida Governor, Andrew Gillum Concedes
RiRi hopped on Instagram Monday and encouraged Florida locals to pull through for Gillum and music mogul Diddy's event. Yet, an FBI investigation into alleged corruption at Tallahassee City Hall hurt his chances of winning the election.

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.

Florida teen accused of strangling mom after arguing over bad grade
However the details did not add up after Cleavenger's architect firm said she didn't show up to work that morning. Pagliari that he dreamed of becoming a homicide detective like him one day.

Mauricio Pochettino: Spurs can progress in Champions League after PSV win
Striker Kane finally levelled the contest when he fired home after being teed up by substitute Fernando Llorente . PSV defended doggedly for much of the match on a Wembley pitch damaged by recent American football matches.

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.

Muslim women elected to Congress for the first time in history
The seat she won is in a predominantly African American congressional district with few Muslim voters. Minnesota state data showed Omar winning by a large margin, and MI media reported that Tlaib had won.

Priyanka celebrates bachelorette party with bride brigade
Parineeti responded: " Nick Jonas , she is very hard to get!" Priyanka also shared pictures of her bachelorette dress. Priyanka and Nick are reportedly getting married at Rajasthan's Mehrangarh Fort in December.

Republicans fight to keep control of the Senate in 2018 midterms
Trump had been barnstorming through states with competitive Senate races in recent weeks, including Missouri, Texas, and Florida. Joe Donnelly in IN and Republican Marsha Blackburn's win in Tennessee made it much more hard for Democrats to make inroads.

Five men arrested for "vile" effigy of Grenfell Tower tragedy
The Leader of the Royal Borough of Kensington and Chelsea Council, where Grenfell Tower is located, called the video "absolutely disgusting" in a statement .

Other news