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A powerful new opioid drug designed to quickly relieve pain has become the center of controversy as it approaches the approval decision by the US Food and Drug Administration.
The drug, Dsuvia, consists of a single-dose tablet of sufentanil, a synthetic opioid that is much more potent than fentanyl and 500 times more potent than morphine. The tablet is supplied in a preloaded plastic applicator used to deposit the medication under the patient's tongue.
The FDA's Anesthetic and Analgesic Drugs Advisory Committee recently recommended approval of Dsuvia in the United States by 10 votes to 3, and a final decision is expected by Nov. 3. The FDA often follows these recommendations but is not obliged to do so.
Critics, including Dr. Raeford Brown, chairman of the committee, have spoken out against the product, fearing to place another powerful opioid on the US market as the country continues to face a devastating opioid crisis.
Related: More evidence that the epidemic of opioids only worsens
In addition, the design makes it more devious, he told MarketWatch, which means that a person who does not have a prescription could possibly get the product. The consumer advocacy group, Public Citizen, who co-signed a letter with Dr. Brown to FDA officials, and Sen. Edward Markey (D-Mass.), Who recently called on the FDA to ask the FDA to reject the drugs.
"This drug does not bring any progress, in my opinion, compared to opioid preparations available before, but presents a great risk of harm to patients and public health in general," said MarketWatch Brown, professor of 39, anesthesiology and pediatrics at the University of Kentucky. Friday.
In addition, "at this point, in the United States, I do not believe there is a good reason to put another powerful opioid on the street," he said.
Lily: As the opioid crisis raged, Insys pushed higher doses of addictive drugs and encouraged salespeople to "own" doctors.
AcelRx Pharmaceuticals Inc., a drug manufacturer based in Redwood City, California, from the manufacturer of Dsuvia
ACRX, -12.53%
, says that these concerns are unfounded.
The product consists of a 30 microgram tablet, a dose-adjusted amount of sufentanil, which is not stronger than any other opioid already available in the United States, said Dr. Pamela Palmer, co-founder and director of AcelRx Medical Services.
The design, meanwhile, facilitates the use by doctors on a battlefield and could help older or obese patients, for whom an intravenous opioid can be difficult and that it takes some time for oral opioids to start working, she said.
See: Opioids ravage the United States, but they remain the best pain medicine we have.
AcelRx
"When I tell you that this dose is not enough to excite many addicts, it is enough to treat an elderly woman who has had a hip replacement," Palmer said.
Mr. Palmer told MarketWatch that the AcelRx product would only be distributed in facilities under medical supervision, such as a hospital or outpatient surgery center, which must be certified by the Risk Assessment and Mitigation Strategy Program. risks (REMS) of the company. Dsuvia would not be available at a pharmacy, for example, Walgreens, said Palmer.
She also referred to the recommendation of the FDA Advisory Committee for the product.
Brown was not present at the vote because a major anesthesiology conference was taking place at the same time – something he says he spoke to the FDA, although the regulator did not say anything about it. did not move the meeting.
But Brown said that although the FDA has been working hard to try to find a way to prevent prescription opioid diversion, this has turned out to be a difficult task. The REMS programs are designed to avoid these types of damage, but have failed, he said.
His advisory committee recently reviewed a REMS program for a transmucosal fentanyl intended solely for cancer patients, he said, "and it became apparent that it was no longer possible to control this drug once it's been put on the market ".
"In reality, once a drug is marketed, the FDA has no control over it. So that becomes the [Drug Enforcement Administration’s] problem, and the DEA has enough trouble preventing black tar heroin from entering the country, "said Brown.
AcelRx shares fell by 13.7% in an extremely intense trading on Friday. The company's shares have jumped 21% in the last three months, while the S & P 500 had dropped 1%.
SPX, -0.04%
and a 1.7% rise in the Dow Jones Industrial Average
DJIA, + 0.26%
.
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