The Atlanta Journal-Constitution
There’s a new fear about the opioid epidemic
People on front lines of epidemic fear powerful new drug, Dsuvia.
A new drug that gained U.S. Food and Drug Administration approval Friday has raised the fears of Georgians on the front lines of fighting the opioid epidemic.
Dsuvia, made by a 13-year-old California-based company, AcelRx Pharmaceuticals, is a powerful opioid that is more potent than morphine and stronger than fentanyl.
It’s “very scary,” said Alpharetta resident Dawn Camarda, who formed the Blake Meier New Life Foundation after her 26-year-old son died of a fentanyl overdose in a West Palm Beach motel room in 2016.
“If this drug does make it through, I certainly hope there are strict regulations,” she said. “If this drug hits the street, it will be even more devastating than fentanyl. I wish the drug companies would work on a nonaddictive painkiller rather than a more potent opioid, as we all know this new drug will become a big issue with addiction.”
The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee last month voted 10-3 to approve Dsuvia.
The fast-acting product contains a synthetic painkiller known as sufentanil and is meant to be taken in a supervised medical setting, such as hospitals, emergency departments, surgical centers or by the military on the battlefield. The new product comes in a form that dissolves quickly under the tongue.
The FDA’s commissioner, Dr.
Scott Gottlieb, acknowledged concerns about opioid use, but said at the same time, the agency was “also paying careful attention to the needs of patients and physicians managing pain.”
Dsuvia, he said in a statement, is best suited for patients who may not be able to swallow oral medication, and where access to intravenous pain relief is not possible, including the battlefield.
Dr. Pamela Palmer, cofounder and chief medical officer at AcelRx, also defended the drug.
It fills a much-needed gap, she said.
“It’s not at all for prescription use, and it’s certainly not for use at home,” Palmer said.
The product is for moderate and severe pain. “There is currently no way available to rapidly treat your pain without sticking you with a needle,” Palmer said. “If you broke your femur and are obese or elderly or on a blood thinner, that can be very painful with a lot of bruising. If you take a pill, you have to swallow it with water and wait for it to kick in, which could take up to an hour. Right now, that’s all that’s available. For the first time, we’ve developed a small tablet that goes under the tongue and dissolves in about six minutes.”
There aren’t pain medications like that currently available for patients who don’t have cancer.
Attention on Dsuvia comes during a rare bipartisan effort, in which President Donald Trump recently signed sweeping legislation that, among other things, improves access to treatment and authorizes research into nonaddictive drugs that could be used for controlling pain.
So the fact an even more powerful drug will soon be available for use is confusing to Farley Barge, co-founder of Navigate Recovery Gwinnett. He has watched several relatives and friends struggle with opioid and alcohol addiction. “Like most of the opioid drugs, the potential for abuse is great.”
He’s worried that the drug could still fall into the wrong hands, especially if there is demand. “We know that one reason people give for taking drugs is that typically what a patient is taking stops working over time. Their tolerance level for opioids increases. So this drug is just another step in the process. I question whose interests we’re watching out for here.”
In 2016, more than 63,000 people in the United States died of an opioid overdose, according to the Centers for Disease Control and Prevention. Although deaths might have involved more than one drug, prescription and/or illicit opioids were involved in 66.4 percent of the cases.
“Several people we know have said one of the worst things they ever did was to follow their doctor’s orders and they ended up addicted to opioids,” Barge said. “We do the same thing over and over again and expect a different result. With FDA approval, these types of drugs are just upping the ante.”
Palmer said AcelRx has taken steps to monitor the use and supplies of Dsuvia, including requiring a Risk Evaluation and Mitigation Strategy to accompany the drug.
“I’m not saying that drugs delivered to hospitals never get stolen or abused, but that’s a tiny sliver” of the opioid epidemic problem, Palmer said.
Dr. Gaylord Lopez, director of the Georgia Poison Center, still worries, however.
“Obviously you always have to blink twice, especially in light of the opioid epidemic, when you hear about a new product coming into the marketplace,” he said. “It’s another straw on the camel’s back. The problem is the camel’s back is already broken.”