Dsuvia is a tablet that would be used in hospital settings only. Some experts say it would still fuel the opioid addiction crisis.
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.
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.”
Healthline reached out to several medical professionals — those treating both drug addiction and pain management — to see where their sentiments lie regarding the approval of a sufentanil-based product on the market.
Some agreed with Brown’s warning to the FDA.
Dr. Gloria Dunkin, medical director of Futures Recovery Healthcare in Palm Beach, Florida, said the new form of sufentanil will only worsen the opioid epidemic.
“Dr. Brown is, rightly, focusing on the potential dangers and consequences of introducing this medication to the market,” she said. “We want to avoid more people dying from overdoses. Approving a sublingual tablet of sufentanil has a unique potential to only cause more.”
Dr. Andrew King, clinical assistant professor and medical toxicology fellowship director at the Detroit Medical Center, said Brown’s concerns, including its potential for diversion, misuse, and death are “right on.”
Brown told Healthline that all opioids have addictive potential, and highly potent drugs are more dangerous and have narrow therapeutic uses, despite what the manufacturer says.
“We are seeing highly potent opioids added to heroin lead to increasing rates of mortality,” he said. “Sufentanil is highly potent, small, and easily diverted because it is small and potent. It is unclear if there is a real clinical need for this drug in this formulation.”
Dr. Harold S. Minkowitz, an anesthesiologist in Houston who has participated in research-authored papers on sufentanil with AcelRx’s Palmer, says that after witnessing more than 200 patients dosed with the medication, he believes the new drug will be “excellent” in assisting physicians who treat acute pain.
“Sufentanil has undergone a rigorous clinical development program and I feel that not approving it would send a message to drug developers that they should not be investing any money into developing novel agents,” Minkowitz told Healthline.
Deni Carise, PhD, the chief clinical officer for the Recovery Centers of America and adjunct clinical assistant professor at the University of Pennsylvania, said she applauds Brown’s comments.
Carise said since sufentanil has been approved in an injectable form for more than 20 years, the introduction of a new form that makes it easier to get into the hands of those who may use it illicitly “is dangerous.”
If the FDA doesn’t approve it for sale in the United States, Carise says the message is clear.
“This country doesn’t need another, more easily abused form of the potent opioid fentanyl to be approved,” she told Healthline. “The FDA has consistently shown an inability to safeguard our citizens from deadly prescription drugs. They are not equipped to do post-marketing analysis of prescribing behavior, and there has been evidence that there will be little in the way of education on appropriate prescribing practices.”
Dr. Sheldon Opperman, an anesthesiologist and co-founder of the chronic pain center KetaTherapy, said experts have been using multiple methods or medications to manage pain to cut down on the use of opioids during surgery and after.
“We do not need a drug that is over 10 times stronger than fentanyl out in the market, unless we wish to see more abuse and overdoses to add to an already perplexing epidemic,” he told Healthline.
Dr. Jon Koning, a pain management physician at Texas Health Plano, says there’s a definite need for new, abuse-deterrent opioids but points to issues such as the prescribing of Subsys — a fentanyl spray — and the combination opioid Opana ER, which was taken off the market last year.
“Allowing a much more potent drug like sufentanil to come on the market is directly contrary to our efforts to curb the opioid epidemic and the opioid overdose rates,” he said.
The FDA isn’t required to follow recommendations from its advisory committee and is set to make a determination on Dsuvia by November 5.
Palmer, the co-founder of AcelRx, says the response from the FDA has been positive so far because doctors testified about the advantages of noninvasive options for fast-acting acute painkillers, which is why the Department of Defense came to her.
Because it will be approved for use only in medically supervised scenarios, Palmer says her company’s product won’t contribute to the country’s addiction and overdose crisis.
“My heart goes out to everyone in that struggle, but that’s not who our drug would impact,” she said. “There’s an inpatient crisis that’s not getting the same kind of attention, and it’s affecting people’s health.”