Amid deepening addiction crisis, FDA approves powerful new opioid

Despite the ongoing opioid crisis plaguing the nation, the US Food and Drug Administration on Friday approve...

Posted: Nov 5, 2018 3:06 AM
Updated: Nov 5, 2018 3:06 AM

Despite the ongoing opioid crisis plaguing the nation, the US Food and Drug Administration on Friday approved a new opioid medication five to 10 times more powerful than fentanyl.

Dsuvia, made by AcelRx Pharmaceuticals Inc., is a tablet in a single-dose, prefilled applicator to be administered under the tongue by health care providers to patients in settings such as hospitals, surgical centers and emergency rooms, according to the company.

Business and industry sectors

Business, economy and trade

Controlled substances

Drugs and society

Epidemics and outbreaks

Government organizations - US

Health and medical

Opioid epidemic

Opioids

Pharmaceutical industry

Pharmaceuticals and biotechnology

Pharmaceuticals and prescription drugs

Prescription drug abuse

Public health

Society

Substance abuse

US Department of Health and Human Services

US federal departments and agencies

US Food and Drug Administration

Drug overdoses

Medical treatments and procedures

Pain management

Consumer protection

Drug and medical devices approval

Pharmaceuticals and biotechnology regulation and policy

FDA Commissioner Dr. 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."

In April, Gottlieb told CNN Chief Medical Correspondent Dr. Sanjay Gupta that opioids are the biggest crisis facing the nation, a crisis fueled by overprescribing. The numbers say it all: More people die in the US each year from drug overdoses than from breast cancer.

Following the approval of Dsuvia, Gottlieb acknowledged that opioids are a unique class of medications. "I recognize that the debate goes beyond the characteristics of this particular product or the actions that we're taking to mitigate this drug's risks and preserve its differentiated benefits. We won't sidestep what I believe is the real underlying source of discontent among the critics of this approval -- the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction," he said.

But the criticism was quick. "The U.S. Food and Drug Administration (FDA) is recklessly and needlessly endangering people by approving a super-strong opioid," a statement from the public advocacy group Public Citizen said in response to the approval. The group noted that Dsuvia is five to 10 times more powerful than fentanyl and 1,000 times more potent than morphine.

"It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly," said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group.

"DSUVIA will not be available in retail pharmacies or for outpatient use. DSUVIA will only be distributed to health care settings certified in the DSUVIA Risk Evaluation and Mitigation Strategy (REMS) program following attestation by an authorized representative that the healthcare setting will comply with appropriate dispensing and use restrictions of DSUVIA," AcelRx said.

Other restrictions, according to the FDA, include that it cannot be used for more than 72 hours and will have the same black-box warnings as are required for all opioids about the risk of misuse and abuse that can lead to addiction and overdose death.

"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.

The statement noted the benefit the drug could have for soldiers injured on the battlefield. It notes that the Department of Defense was involved in its development and that it was a priority for the Pentagon because it "fills an unmet need."

The same drug, with the chemical name sufentanil, is already available as an IV medication. In its newly approved form, it is an option for patients with acute pain who are not able to receive an IV or are unable to swallow a pill. Dsuvia was approved by the European Medicines Agency in June under the name Dzuveo.

Dsuvia was rejected by an FDA advisory committee in 2017 because the committee wanted more data. AcelRx returned to the committee this year, and on October 12 the drug was recommended for approval. It is expected to be available in the first quarter of next year.

"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. Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients.

West Lafayette
Clear
86° wxIcon
Hi: 87° Lo: 71°
Feels Like: 92°
Kokomo
Clear
84° wxIcon
Hi: 87° Lo: 68°
Feels Like: 90°
Rensselaer
Scattered Clouds
82° wxIcon
Hi: 86° Lo: 68°
Feels Like: 87°
Fowler
Scattered Clouds
82° wxIcon
Hi: 83° Lo: 69°
Feels Like: 87°
Williamsport
Clear
83° wxIcon
Hi: 85° Lo: 70°
Feels Like: 88°
Crawfordsville
Clear
80° wxIcon
Hi: 84° Lo: 70°
Feels Like: 82°
Frankfort
Clear
82° wxIcon
Hi: 85° Lo: 69°
Feels Like: 85°
Delphi
Clear
84° wxIcon
Hi: 88° Lo: 69°
Feels Like: 87°
Monticello
Clear
84° wxIcon
Hi: 89° Lo: 68°
Feels Like: 87°
Logansport
Scattered Clouds
81° wxIcon
Hi: 85° Lo: 68°
Feels Like: 84°
Active Pattern Ahead
WLFI Radar
WLFI Temps
WLFI Planner

Indiana Coronavirus Cases

Data is updated nightly.

Confirmed Cases: 73287

Reported Deaths: 3036
CountyConfirmedDeaths
Marion15701725
Lake7496275
Elkhart480184
Allen3835163
St. Joseph342381
Hamilton2723104
Vanderburgh192213
Hendricks1871108
Cass17869
Johnson1741118
Porter129439
Clark120247
Tippecanoe118911
Madison94365
LaPorte89430
Howard88465
Kosciusko84712
Bartholomew78047
Marshall77422
Floyd77246
Monroe74630
Delaware71452
Dubois68712
Boone67246
Noble66329
Hancock64738
Vigo61910
Jackson5855
Warrick57930
LaGrange55710
Shelby54627
Grant52630
Dearborn49628
Morgan46734
Clinton4303
Henry37620
Wayne36810
White36110
Montgomery35221
Lawrence34227
Decatur33532
Harrison32723
Putnam2868
Miami2692
Scott26610
Daviess26420
Greene24634
Franklin24114
Jasper2342
DeKalb2304
Jennings22412
Gibson2214
Steuben2073
Ripley1997
Fayette1867
Carroll1852
Perry18412
Starke1777
Posey1700
Orange16924
Wabash1653
Fulton1642
Wells1622
Jefferson1602
Knox1510
Whitley1516
Washington1391
Tipton1379
Spencer1313
Huntington1223
Newton11810
Randolph1184
Clay1165
Sullivan1131
Adams962
Jay910
Owen871
Pulaski791
Rush764
Brown731
Fountain732
Blackford632
Ohio635
Benton610
Pike530
Parke511
Vermillion490
Switzerland460
Crawford440
Martin430
Union390
Warren221
Unassigned0202

COVID-19 Important links and resources

As the spread of COVID-19, or as it's more commonly known as the coronavirus continues, this page will serve as your one-stop for the resources you need to stay informed and to keep you and your family safe. CLICK HERE

Closings related to the prevention of the COVID-19 can be found on our Closings page.

Community Events