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Should FDA Approve ‘Super Opioid’ That’s Stronger Than Fentanyl?

When Dr. Pamela Palmer was the head of the pain management center at the University of California San Francisco Medical Center, she also testified in wrongful death lawsuits against hospitals.

Too often, she says, those cases involved intravenous painkillers that were administered at too high of a dose.

“I saw enough of these that I wanted to start a company that could address these problems,” she told Healthline.

So, in 2005, she co-founded AcelRx Pharmaceuticals, Inc.

Their latest product before the Food and Drug Administration (FDA) is called Dsuvia.

It’s a tablet that dissolves under a patient’s tongue to deliver fast pain relief during extreme trauma, such as a broken femur or a gunshot wound.

Because of its capabilities on the battlefield, it even received funding from the U.S. Army Medical Research and Materiel Command.

Dsuvia is meant to be used only in a supervised setting, such as an emergency room.

It contains 30 micrograms of a synthetic opioid painkiller known as sufentanil, which is 5 to 10 times more potent than fentanyl, and 1,000 times more potent than morphine.

Sufentanil itself is nothing new. It’s been approved in intravenous form since 1984.

Palmer says this new version would help with dosing problems, as well as patients who might not be fit for an IV.

“There’s a huge advantage to not sticking a person with a needle,” she said.

AcelRx estimates Dsuvia’s market potential to be approximately $1.1 billion in the United States alone, according to its website.

AcelRx applied for a new drug status with the FDA in 2016 and received an official response in October 2017, the same month the opioid crisis was declared a public health emergency.

The Centers for Disease Control and Prevention (CDC) reports there were more than 42,000 opioid overdose deaths in 2016. That was two-thirds of all drug overdose deaths that year.

Because the United States is in the midst of an opioid addiction epidemic, some medical experts argue the FDA shouldn’t be approving a stronger and easier to digest opioid. This includes the chair of its own advisory committee dealing with opioids.

The mere presence of Dsuvia shows how the medical community is at odds when it comes to balancing addiction and overdoses with effectively managing a person’s pain.

There are all kinds of drugs to treat all kinds of pain, so those on both sides of this battle are questioning why — and why not — a new delivery method of a so-called “super opioid” is needed.

Differing opinions

Earlier this week, the head of the FDA issued multiple statements regarding the opioid addiction and overdose crisis.

Citing statistics of overdose deaths, FDA Commissioner Dr. Scott Gottlieb said it’s “critical that we continue to tackle this human tragedy from all fronts.”

That included looking at new ways to increase the availability of naloxone, a drug that can immediately reverse an opioid overdose, whether it be from heroin or increasingly potent pharmaceutical drugs such as fentanyl.

The second announcement regarded the targeting of 465 websites that “illegally sell potentially dangerous, unapproved versions” of prescription drugs, including opioid painkillers.

“This is a global cooperative effort, led by Interpol, to combat the unlawful sale and distribution of illegal and potentially counterfeit medical products sold on the internet,” Gottlieb’s statementread.

The latest announcement regarded a bipartisan bill that President Donald Trump signed into law that expands substance abuse treatment to patients under government-funded insurance plans. The bill further targets those online pharmacies, and provides grants to those addressing the addiction and overdose crisis.

But at the same time, the head of FDA’s own advisory committee is warning the administration that its potential approval of the new version of sufentanil will only make overdoses that much more likely.

After all, experts say, it isn’t doing much to monitor or control the opioids that fueled the epidemic.

Earlier this month, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted 10–3 to approve AcelRx’s Dsuvia.

Its chair, Dr. Raeford Brown, wasn’t at the meeting. But, together with three members of the Public Citizen’s Health Research Group, Brown followed up with a letter to Gottlieb and others at the FDA.

One major concern Brown and other experts have is diversion, or the drug changing hands from people who use it for medical need to those who use it to support an addiction.

“It is so potent, that abusers of this intravenous formulation often die when they inject the first dose,” Brown said in the letter. “I predict that we will encounter diversion, abuse, and death within the early months of its availability on the market.”

Brown argues that because there hasn’t been appropriate follow-up — demonstration of safety, assessing who is taking the drug, how often prescribing is appropriate, and the risk of having yet another opioid on the market — of all other opioid drugs during the past decade, he believes the new drug shouldn’t be approved.

“Sublingual sufentanil represents a danger to the general public health and will make our job of protecting Americans more difficult,” the statement said. “It has no truly unique benefits and will only add to the worsening, not the mitigation, of the opioid epidemic in this country.”