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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 2:06 AM
Updated: Nov 5, 2018 2:06 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.

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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.

Mississippi Coronavirus Cases

Data is updated nightly.

Cases: 154411

Reported Deaths: 3836
CountyCasesDeaths
DeSoto10409104
Hinds10279202
Harrison7313112
Jackson6566128
Rankin5887106
Lee529496
Madison5014107
Forrest389786
Jones369088
Lauderdale3594147
Lafayette338253
Washington3246108
Lamar297850
Oktibbeha252362
Lowndes247064
Bolivar244384
Panola232653
Neshoba2249121
Marshall222851
Leflore208591
Monroe206778
Pontotoc204231
Lincoln197366
Sunflower192655
Warren180258
Tate177751
Union171926
Copiah167940
Pike165359
Yazoo160140
Scott159430
Itawamba157635
Alcorn155628
Pearl River155368
Coahoma152743
Simpson152653
Prentiss151331
Adams144752
Grenada143345
Leake139744
Holmes133461
Covington128639
Tippah128430
George128325
Winston125526
Hancock124341
Wayne121323
Marion119446
Attala119334
Tishomingo112443
Chickasaw109432
Newton108229
Tallahatchie98127
Clay94727
Clarke93653
Jasper85223
Stone80615
Calhoun78713
Walthall77629
Montgomery76926
Carroll74115
Lawrence73814
Smith73216
Yalobusha73128
Noxubee72717
Perry68326
Tunica62619
Greene61522
Jefferson Davis59017
Claiborne58916
Amite56615
Humphreys54719
Benton50018
Quitman5007
Webster46714
Kemper45018
Wilkinson40522
Jefferson37112
Choctaw3617
Franklin3555
Sharkey32417
Issaquena1204
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Alabama Coronavirus Cases

Cases: 252900

Reported Deaths: 3638
CountyCasesDeaths
Jefferson33526501
Mobile20103365
Madison13723151
Tuscaloosa13366154
Montgomery12552236
Shelby1079677
Baldwin9051137
Lee787266
Morgan696451
Calhoun6598121
Etowah656167
Marshall647357
Houston541038
DeKalb498137
Cullman462443
St. Clair441956
Limestone440445
Lauderdale426754
Elmore421164
Walker3735111
Talladega370157
Jackson340423
Colbert332042
Blount306140
Autauga281842
Franklin257434
Coffee250015
Dale239054
Dallas231532
Chilton228939
Russell22663
Covington225034
Escambia202331
Tallapoosa187291
Chambers182750
Pike161514
Clarke161019
Marion144736
Winston137523
Lawrence133436
Pickens126518
Geneva12508
Marengo123424
Bibb120418
Barbour118911
Butler118642
Randolph105522
Cherokee105124
Hale98131
Fayette94616
Washington93219
Clay92824
Henry8896
Monroe83011
Lowndes80929
Cleburne78814
Macon75522
Crenshaw72230
Bullock70119
Lamar7018
Conecuh70014
Perry6916
Wilcox64818
Sumter58622
Greene43518
Choctaw43114
Coosa3664
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