The U.S. Food and Drug Administration’s Anesthetic and Analgesic Drug Products Advisory Committee last month voted 10-3 to approve Dsuvia. The FDA gave final approval Friday.
The fast-acting product contains a synthetic painkiller known as sufentanil and is meant to be taken in a supervised medical setting, such as a hospital emergency department. The new product comes in tablet form that dissolves quickly under the tongue.
Dr. Pamela Palmer, co-founder and chief medical officer at AcelRx, defended the drug.
It fills a much-needed gap, she said.
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“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.”
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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 is getting approved 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 said.
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," he said. "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.”
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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 use and supplies of 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.”