Published: Oct 21, 2018 11:25 a.m. ET
The product consists of an opioid that is 500 times stronger than morphine but drugmaker defends its need
A sign for Naloxone hangs on a wall at a class for opioid overdose prevention held in New York City in 2017.
A new, potent opioid medication intended for quick pain relief has become the center of a maelstrom of controversy as the drug nears a U.S. Food and Drug Administration approval decision.
The drug, Dsuvia, consists of a single-dose tablet of sufentanil, a synthetic opioid that is many times more potent than fentanyl and 500 times stronger than morphine. The tablet comes in a preloaded plastic applicator that is used to deposit the medication under a patient’s tongue.
The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee recently recommended Dsuvia for U.S. approval, with a 10-3 vote, and an final decision is expected by Nov. 3. The FDA often follows such recommendations but is not obligated to do so.
But critics, most notably Dr. Raeford Brown, the chair of the committee, have spoken out against the product, worrying about putting another strong opioid on the U.S. market as the country continues to wrestle with a devastating opioid crisis.
In addition, the design makes it more divertible, he told MarketWatch, meaning that an individual who doesn’t have a prescription might be able to obtain the product. Other voices speaking out against the drug include the consumer advocacy group Public Citizen, which co-signed a letter with Dr. Brown to FDA leaders, and Sen. Edward Markey (D-Mass.), who recently called on the FDA to reject the medication.
“This drug offers no advance, in my mind, over previously available opioid formulations, but provides great risk of harm to patients and the general public health,” Brown, who is a professor of anesthesiology and pediatrics at the University of Kentucky, told MarketWatch on Friday.
Moreover, “I just don’t believe at this point in the U.S. that there is any good reason to put another potent opioid on the streets,” he said.
Dsuvia’s manufacturer, Redwood City, Calif.-based drugmaker AcelRx Pharmaceuticals Inc. ACRX, -12.53% , says that these concerns are unfounded.
The product is made up of one, 30 microgram tablet, a dose-adjusted amount of sufentanil that is no stronger than any other opioid already available in the U.S., said Dr. Pamela Palmer, co-founder and chief medical officer of AcelRx.
The design, meanwhile, makes it easier for medics to use on a battlefield, and could help elderly or obese patients, for whom an intravenous opioid can be difficult and oral opioids take some time to start working, she said.
AcelRx’s opioid product Dsuvia consists of a tablet of the potent opioid sufentanil. Co-founder and Chief Medical Officer Dr. Pamela Palmer says that because the product is dose-adjusted, it is no stronger than any other opioid already available in the U.S.
“When I tell you this dose is not enough to get many drug addicts excited about it — it’s enough drug to treat an elderly woman who had a hip replacement,” Palmer said.
Palmer told MarketWatch that AcelRx’s product would only be distributed in medically supervised settings, like a hospital or ambulatory surgery center, which have to be certified through the company’s Risk Evaluation and Mitigation Strategies (REMS) program. Dsuvia wouldn’t be available at a pharmacy, say, for example, Walgreens, Palmer said.
She also pointed to the FDA advisory committee’s recommendation in support of the product.
Brown was not at the vote, as a major anesthesiology conference was happening at the same time — something he says he told the FDA about, though the regulator did not move the meeting.
But Brown said that while the FDA has worked hard to try and find a way to prevent diversion of prescription opioids, it has proven a difficult task. REMS programs are intended to avoid these types of harms but haven’t been successful, he said.
His advisory committee recently reviewed a REMS program for a transmucosal fentanyl that was only supposed to be for patients with cancer pain, he said, “and it became clear that there was no controlling that drug once it came to market.”
“In reality, once a drug is marketed, the FDA has no control over it. Then it becomes the [Drug Enforcement Administration’s] problem, and the DEA has enough problems with trying to keep black-tar heroin out of the country,” Brown said.
AcelRx shares dropped 13.7% in extremely heavy Friday trade. Company shares have surged 21% over the last three months, compared with a 1% decline in the S&P 500 SPX, -0.04% and a 1.7% rise in the Dow Jones Industrial AverageDJIA, +0.26% . (Click to Source)
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