FDA approves powerful new opioid

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.

Posted: Nov 4, 2018 9:31 AM

(CNN) -- 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.

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.

The-CNN-Wire
™ & © 2018 Cable News Network, Inc., a Time Warner Company. All rights reserved.

Terre Haute
Clear
72° wxIcon
Hi: 77° Lo: 51°
Feels Like: 72°
Robinson
Clear
66° wxIcon
Hi: 72° Lo: 48°
Feels Like: 66°
Indianapolis
Overcast
71° wxIcon
Hi: 75° Lo: 54°
Feels Like: 71°
Rockville
Clear
70° wxIcon
Hi: 78° Lo: 50°
Feels Like: 70°
Casey
Clear
71° wxIcon
Hi: 73° Lo: 50°
Feels Like: 71°
Brazil
Clear
72° wxIcon
Hi: 77° Lo: 50°
Feels Like: 72°
Marshall
Clear
72° wxIcon
Hi: 76° Lo: 49°
Feels Like: 72°
A Pleasant Overnight
WTHI Planner
WTHI Temps
WTHI Radar

WTHI Events

 

Illinois Coronavirus Cases

(Widget updates once daily at 7 p.m. CT)

Confirmed Cases: 279453

Reported Deaths: 8722
CountyConfirmedDeaths
Cook1400785172
DuPage16883551
Lake16489486
Will13539373
Kane12716325
St. Clair6339187
Madison5414131
Winnebago5399149
McHenry4446118
Champaign441120
Peoria325648
McLean318820
Rock Island282771
Kankakee266076
Sangamon226744
Unassigned2250236
Kendall193225
LaSalle163056
Tazewell160920
DeKalb148038
Macon141740
Coles136630
Williamson133737
Jackson124224
Clinton108420
Boone105623
Adams102010
Randolph92311
Effingham8341
Whiteside69420
Ogle6416
Grundy6355
Monroe62715
Morgan62523
Henry6245
Vermilion6224
Knox6133
Bureau58711
Jefferson56438
Marion5160
Franklin4992
Macoupin4987
Union49724
Stephenson4756
McDonough45315
Christian44310
Logan4361
Woodford4026
Crawford3892
Jersey38514
Cass38411
Iroquois35719
Shelby3524
Fayette3513
Livingston3406
Perry33815
Lee3331
Montgomery33113
Warren3072
Bond2944
Douglas2816
Saline2783
Lawrence2502
Wayne2495
Jo Daviess2432
Greene2167
Carroll2124
Moultrie2073
Cumberland2004
Jasper1999
Washington1971
Hancock1943
Pulaski1591
Richland1594
White1590
Clark1512
Fulton1480
Wabash1461
Johnson1440
Clay1410
Piatt1310
Mason1281
Mercer1275
Menard1190
Pike1101
Edgar1097
De Witt1031
Ford985
Massac962
Marshall940
Scott740
Alexander731
Gallatin672
Hamilton670
Henderson630
Edwards610
Putnam520
Stark502
Schuyler450
Calhoun440
Brown410
Hardin360
Pope261
Out of IL20

Indiana Coronavirus Cases

(Widget updates once daily at 8 p.m. ET)

Confirmed Cases: 112626

Reported Deaths: 3520
CountyConfirmedDeaths
Marion20832759
Lake10292318
Elkhart6415109
St. Joseph6156102
Allen6029200
Hamilton4724109
Vanderburgh344530
Hendricks2673122
Monroe247436
Tippecanoe226913
Johnson2268123
Clark215056
Porter207845
Cass19329
Delaware188261
Vigo178123
Madison159575
LaPorte137739
Floyd131461
Howard128563
Kosciusko120217
Warrick119936
Bartholomew115357
Marshall98924
Dubois95418
Boone95146
Hancock91143
Grant89133
Noble89132
Henry77024
Wayne74414
Jackson7409
Morgan70038
Shelby66529
Daviess64427
Dearborn63228
LaGrange63111
Clinton59212
Harrison56024
Putnam53710
Lawrence50528
Montgomery50521
Knox5019
Gibson4854
White48114
DeKalb45611
Decatur45439
Miami4263
Fayette41813
Greene41835
Jasper3862
Steuben3707
Scott35610
Sullivan33012
Jennings31212
Posey3060
Franklin29925
Clay2935
Orange28524
Ripley2838
Carroll27013
Wabash2618
Washington2611
Starke2537
Whitley2526
Wells2482
Adams2453
Jefferson2443
Fulton2342
Huntington2223
Tipton21722
Spencer2153
Perry21413
Randolph2087
Jay1730
Newton17111
Owen1651
Martin1640
Rush1524
Pike1401
Vermillion1260
Fountain1182
Pulaski1151
Blackford1133
Crawford1030
Brown1023
Parke941
Benton880
Union770
Ohio767
Switzerland700
Warren391
Unassigned0225