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.

Indiana Coronavirus Cases

Data is updated nightly.

Confirmed Cases: 49063

Reported Deaths: 2732
CountyConfirmedDeaths
Marion11760689
Lake5276246
Elkhart340255
Allen2835133
St. Joseph200169
Cass16429
Hamilton1608101
Hendricks1425100
Johnson1296118
Porter76738
Tippecanoe7359
Clark66844
Madison66764
Bartholomew59145
Vanderburgh5876
LaPorte58326
Howard58058
Kosciusko5624
Marshall5016
Noble48528
LaGrange4779
Jackson4733
Boone45443
Delaware45252
Hancock45236
Shelby43125
Floyd38444
Morgan32731
Monroe30928
Montgomery29720
Grant29626
Clinton2902
Dubois2886
Henry28216
White26610
Decatur25432
Lawrence24825
Dearborn23823
Vigo2388
Warrick22729
Harrison21622
Greene19032
Miami1862
Jennings17712
Putnam1708
DeKalb1634
Scott1628
Daviess14817
Wayne1436
Orange13623
Perry1359
Steuben1302
Franklin1268
Ripley1247
Jasper1232
Wabash1142
Carroll1102
Fayette1037
Newton9910
Gibson982
Whitley975
Starke943
Randolph804
Huntington782
Jefferson762
Wells751
Fulton721
Jay680
Washington671
Pulaski661
Knox640
Clay604
Rush583
Owen501
Adams491
Benton480
Posey450
Sullivan451
Spencer441
Brown421
Blackford392
Crawford320
Fountain322
Tipton311
Switzerland280
Parke240
Martin220
Ohio180
Vermillion140
Warren141
Union130
Pike110
Unassigned0193

Ohio Coronavirus Cases

Data is updated nightly.

Confirmed Cases: 60181

Reported Deaths: 2991
CountyConfirmedDeaths
Franklin10879439
Cuyahoga8277383
Hamilton6287206
Lucas2836303
Marion273639
Summit2241207
Pickaway220541
Montgomery220131
Mahoning1861239
Butler167447
Columbiana130960
Stark1156113
Lorain106468
Trumbull99774
Warren89525
Clark7809
Delaware61715
Fairfield60517
Tuscarawas58510
Belmont55522
Medina54332
Lake52920
Licking52012
Miami47531
Portage46159
Wood45251
Ashtabula43744
Clermont4317
Geauga41443
Wayne36552
Richland3515
Allen32841
Mercer2909
Greene2879
Darke25326
Erie25022
Holmes2453
Huron2282
Madison2029
Ottawa16024
Washington14020
Sandusky13814
Crawford1365
Putnam13215
Ross1323
Coshocton1302
Hardin12312
Morrow1181
Auglaize1074
Jefferson922
Union921
Monroe8917
Muskingum891
Hancock831
Preble801
Athens791
Hocking798
Guernsey763
Lawrence740
Williams722
Shelby704
Clinton680
Logan651
Fulton630
Ashland621
Carroll603
Wyandot605
Brown591
Scioto540
Defiance533
Knox531
Fayette480
Highland461
Champaign441
Van Wert420
Perry371
Seneca352
Henry320
Jackson260
Paulding260
Adams241
Pike240
Vinton222
Gallia201
Harrison121
Meigs120
Morgan110
Noble110
Unassigned00
Fort Wayne
Scattered Clouds
81° wxIcon
Hi: 92° Lo: 72°
Feels Like: 85°
Angola
Overcast
75° wxIcon
Hi: 90° Lo: 72°
Feels Like: 75°
Huntington
Few Clouds
78° wxIcon
Hi: 90° Lo: 72°
Feels Like: 80°
Decatur
Clear
72° wxIcon
Hi: 91° Lo: 72°
Feels Like: 72°
Van Wert
Clear
72° wxIcon
Hi: 92° Lo: 72°
Feels Like: 72°
AM Storms, Slightly Cooler Friday
WFFT Radar
WFFT Temperatures
WFFT National

Community Events