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FDA Approves Powerful Opioid in Tablet Form: Sufentanil (Dsuvia)

posted by martyb on Sunday November 04 2018, @04:33AM   
from the need-more-opioids-to-fight-the-opioid-epidemic dept.

takyon writes:

FDA approves powerful new opioid in 'terrible' decision

The Food and Drug Administration approved a powerful new opioid Friday, despite strong criticism and accusations that it bypassed its own advisory process to do it.

The new drug, Dsuvia, is a tablet that goes under the tongue. It is designed for use in the battlefield and in other emergency situations to treat intense, acute pain.

Known generically as sufentanil, it's a new formulation of a drug currently given intravenously. Critics say it will be incredibly easy for health workers to pocket and divert the drug to the illicit drug market and because it is so small and concentrated, it will likely kill people who overdose on it.

"This is a dangerous, reckless move," said Dr. Sidney Wolfe senior adviser of Public Citizen's Health Research Group. He questions whether there's need for yet another synthetic opioid when the U.S. is in the throes of an opioid overdose crisis.

Sufentanil is described as 5 to 10 times more potent than fentanyl and 500 times as potent as morphine. Carfentanil is 100 times more potent than fentanyl, but is only approved for the veterinary use of tranquilizing large animals. Sufentanil is the strongest opioid painkiller available for use in humans.

Cannabis and kratom? Exercise caution!

Also at STAT News, NPR, and The Hill.

See also: People on front lines of epidemic fear powerful new drug Dsuvia

Related:

*SPOILER* (click to show) *SPOILER* (click to hide)

Opioid Addiction is Big Business
Heroin, Fentanyl? Meh: Carfentanil is the Latest Killer Opioid
Study: Legal Weed Far Better Than Drug War at Stopping Opioid Overdose Epidemic
President Trump Declares the Opioid Crisis a National Emergency
Study Finds Stark Increase in Opioid-Related Admissions, Deaths in Nation's ICUs
FDA Blocks More Imports of Kratom, Warns Against Use as a Treatment for Opioid Withdrawal
Opioid Commission Drops the Ball, Demonizes Cannabis
U.S. Life Expectancy Continues to Decline Due to Opioid Crisis
FDA Labels Kratom an Opioid
Two More Studies Link Access to Cannabis to Lower Use of Opioids
"Synthetic Opioids" Now Kill More People than Prescription Opioids in the U.S.
U.S. Opioid Deaths May be Plateauing

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Original Submission

• About what we'd expect... About what we'd expect... (Score: 2, Insightful) by Anonymous Coward on Sunday November 04 2018, @04:52AM (3 children)

  by Anonymous Coward on Sunday November 04 2018, @04:52AM (#757506)

  ...from that honest to goodness Big Pharma shill [respectfulinsolence.com] in charge of the FDA today. Talk about the fox guarding the henhouse, but that seems to be depressingly common in this present administration.

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• Re:About what we'd expect... (Score: 3, Informative) by stretch611 on Sunday November 04 2018, @01:18PM

  by stretch611 (6199) on Sunday November 04 2018, @01:18PM (#757591)

  It makes you wonder where the data would lead if you follow the money...

  From NPR [npr.org]:

  Though the advisory committee ultimately voted in favor of the drug, Public Citizen contends the FDA sought to "tilt" the vote's outcome toward approval. Brown, the committee chief, who has been outspoken against certain opioids in the past, says he was unable to attend the advisory committee meeting on Oct. 12 because of a scheduling conflict that he had informed the FDA about months in advance.
  Brown says the FDA decided to hold the meeting anyway — without him.

  And...

  The October meeting also left out most members of another FDA committee — the Drug Safety and Risk Management Advisory Committee — who are often included in regulatory discussions of new opioid drugs. Public Citizen says members of that committee were not invited to attend.

  --
  Now with 5 covid vaccine shots/boosters altering my DNA :P

  Parent

• Re:About what we'd expect... (Score: 0) by Anonymous Coward on Sunday November 04 2018, @01:43PM

  by Anonymous Coward on Sunday November 04 2018, @01:43PM (#757600)

  No, expectations are low, but not this low.

  This seems a very specialized drug with use only in a few authorized instances. Not much profit there.

  So why would a profit driven drug company choose this path?
  Perhaps the cash flow expectations inside the company included expected unauthorized uses.

  It's one thing for a health care company to do their fiducial duty choose max profit over max health.
  (Like making something a chronic condition instead of a cured condition.)

  It's a whole 'nuther level to choose a profit path which has a negative health benefit.
  (That's game plan more expected from nicotine delivery systems. Those folks are relatively honest about what they do.)

  I have no clue if this is the case, but given what opioids have already done and a President interested in the area, it seems strange that his administration would head this way.

  Parent

• Re:About what we'd expect... (Score: 1, Flamebait) by Rich26189 on Sunday November 04 2018, @03:19PM

  by Rich26189 (1377) on Sunday November 04 2018, @03:19PM (#757633)

  "Score: 2, Insightful"?

  depressingly common in this present administration.

  Maybe "1, redundant". Has this never happened prior to Jan. 2017?

  Parent