Ultra-Powerful Opioid Approved by FDA

08 November, 2018, 08:36 | Author: Israel Montgomery
  • FDA OKs powerful opioid pill as alternative to IV painkiller

Public Citizen described the drug as "five to 10 times more potent than fentanyl and 1,000 times more potent than morphine". According to critics, the decision will only fuel the United States' drug crisis even further rather than improving it. "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.

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

A new ultra-powerful opioid is about to make its way into hospitals. According to the administration, prescription opioids were responsible for the most overdose deaths of any illicit drugs since 2001.

The medication won't be available at pharmacies and shouldn't be used for more than 72 hours.

Gottlieb said he would bring a plan to the FDA's Opioid Policy Steering Committee and perhaps Congress.

He states that it is through the restricted use that the drug could be prevented from being abused, misused, or even diverted.

"In this way, [drug companies] would know up front where the opportunities are for developing new drugs that meet the FDA's standards for safety and effectiveness", he wrote.

More news: Popeyes Offering Free Chicken If Derrick Lewis Beats Daniel Cormier

The Food and Drug Administration on Friday approved a new form of an extremely potent opioid to manage acute pain in adults, weeks after the chairman of the advisory committee that reviewed it asked the agency to reject it on grounds that it would likely be abused. Each would come in a plastic applicator that looks like a syringe. It will not be available at your local pharmacy and is designed only for use in a "certified medically-supervised healthcare settings". It is expected to be available in the first quarter of next year.

AcelRx already has approval for 15- and 30-microgram versions of the drug in Europe. In a statement, FDA Commissioner Scott Gottlieb said that "very tight restrictions" will be placed on the drug.

In a November 2 statement released by the consumer group Public Citizen, the chairman of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee criticized the decision, reiterating his opposition he had previously voiced last month in a letter to FDA leaders. "It will be taken by medical personnel and others for whom it has not been prescribed".

Brown added that he has personally tried to resuscitate health care providers who abuse sufentanil, "some successfully". "This action is inconsistent with the charter of the agency", Brown said in a statement Friday. Fewer than 1 percent of people said they acquired opioids that way. Dsuvia is an unnecessary opioid, they say, and its size and potency will appeal to people looking to sell or misuse it.

In one study, the pill provided about the same pain relief to patients as IV morphine.

Including brand name and generic drugs, there are almost 400 opioids now on the market.

Recommended:



Popular

U.S. midterm polls: Alexandria Ocasio Cortez is youngest woman elected to Congress
With the GOP in control of the Senate, Trump will have a majority to confirm his executive and judicial appointments. Polis, who declared victory late Tuesday night, has always been outspoken in favour of marijuana legalisation.

IPad Pro vs MacBook Pro showdown result might just surprise you
The company claims that the A12X Bionic processor makes the iPad Pro faster than 92% of portable computers in the market. Well, the second-generation Apple Pencil attaches to the iPad Pro magnetically and charges wirelessly while doing so.

Farrell tackle a 'penalty'
Shields was born in Masterton to English parents and played for Hurricanes before moving to Wasps and tasting Test rugby with England .

Amazon offering free holiday shipping to everyone
Amazon last month touted improvements in efficiency, which could help it offset costs from more free deliveries. Prime account holders will receive free same-day delivery instead of two-day shipping on eligible items.

Mac Miller's Cause of Death Revealed To Be Fentanyl and Cocaine
Miller, 26, was found unresponsive at his Los Angeles-area home on September 7 and was declared dead soon after. Mac Miller died of an accidental overdose of fentanyl, cocaine and alcohol, according to the coroner.

Man Utd boss Mourinho has concerns about Bournemouth defender Ake
Asked about his team talk at half-time, Mourinho continued: "I started off positive". We assume we'll score two or three goals every game but we can't always do that.

Brock Lesnar is the New Universal Champion
Brock Lesnar recaptured the WWE Universal Championship on Friday at Crown Jewel . AJ Styles "champion vs. champion" rematch at Survivor Series.

Stacey Abrams Slams Brian Kemp’s ‘Desperate’ Hacking Claim Against Georgia Democrats
The Georgia gubernatorial race had already been fraught with a race-laden debate over ballot access and voter suppression. The pitches from Pence and Winfrey clearly fit Abrams' and Kemp's respective strategies.

Format shrinks but West Indies looms large for India
He was the most prolific scorer after captain Kohli in the preceding ODIs where he struck a couple of big hundreds and a 63. From India's perspective, Rohit will be looking to lead by example at a venue where he has set a few landmarks.

Maurizio Sarri makes big Eden Hazard claim after Crystal Palace win
For it was Hazard's free kick, clipped to the far post, that Morata brought down and drilled, left-footed, into the bottom corner. And Pedro made it 3-1 by meeting Marcos Alonso's low cross with an emphatic first-time finish with 20 minutes remaining.