New painkiller Dsuvia is ‘engineering overkill’ for the problem it claims to solve

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• The government’s leading food and drug authority recently
  approved a potent
  new opioid called Dsuvia that dissolves under the
  tongue and can be taken without an IV.
• Several experts
  strongly opposed the approval, which came amidst an
  epidemic of opioid overdose deaths and
  addiction.
• The CEO of the company behind the drug said she created it to
  keep people from being “one step away from being killed by a
  tired nurse or a doctor who ordered the wrong drug.”
• But it’s unclear how big of a problem deaths from medication
  mistakes involving opioids actually are. 
• More importantly, an easier solution to that problem would
  involve simple labeling changes, doctors said.

Throughout Pamela Palmer’s career as chief medical officer of a
specialty hospital for pain management, she repeatedly served as
an expert witness in wrongful death lawsuits involving opioids.
In many of those suits, she said, people died because of a simple
and avoidable medication error, where a clinician had
accidentally given a patient the wrong liquid opioid.

“The problem is, morphine looks like fentanyl looks like
dilaudid,” Palmer told Business Insider. “They all look the
same.”

An anesthesiologist by training, Palmer created a new formulation
of an opioid,
called Dsuvia, explicitly to avoid these kinds of accidental
deaths.

The drug was
approved by by the Food and Drug Administration on November
2. It’s a tiny blue tablet, packaged in a special single-use
applicator, that dissolves under the tongue and begins working to
relieve pain in under an hour.

“It dawned on me — what if we could design an oral form of these
drugs that worked as quickly as the liquid, but basically you
weren’t one step away from being killed by a tired nurse or a
doctor who ordered the wrong drug,” Palmer said. “You could have
almost a fool-proof way of treating someone.”

In addition, Palmer said the new drug would help patients whose
pain can’t be treated efficiently with an IV or an injection,
such as soldiers on the battlefield or patients whose veins are
difficult to find.

In a
statement announcing the new drug’s approval, FDA
commissioner Scott Gottlieb echoed this reasoning. He also said
the Pentagon had “worked closely” with Palmer’s company to
develop the drug for use on the battlefield, where it would fill
what he called a “specific and important, but limited, unmet
medical need.”

Many emergency room doctors appear to
disagree with the need for yet another opioid, however.

While some of them aren’t necessarily opposed to the approval of
a new opioid (thousands of patients need them, even
as thousands
more are dying from
addiction), many of them say Dsuvia aims to solve a set of
problems that doesn’t exist — at least not at the magnitude in
which Palmer presented it.

More importantly, the experts said, there are easier and simpler
ways to prevent mistakes and help make sure that doctors are
giving patients the right dose of pain relievers.

Dsuvia is ‘not a game-changer’

Dozens of potent opioid
painkillers already exist.
Shayanne
Gal/Business Insider

One of the critics is Raeford Brown, an anesthesiologist at the
University of Kentucky and the chair of the FDA advisory
committee that voted in favor of the drug while he was absent.
Brown, who also leads a consumer advocacy group called Public
Citizen,
told NPR that he was not present for the vote because of a
scheduling conflict.

“We have worked very diligently over the last three or four years
to try to improve the public health, to reduce the number of
potent opioids on the street,” Brown told NPR. “I don’t think
this is going to help us in any way.”

Dsuvia is a different formulation of an already available drug
called sufentanil, which is used as an anesthetic for surgeries
and other invasive medical procedures. While sufentanil must be
injected or delivered via an IV, Dsuvia can be taken
orally. 

“We’ve taken a wonderful old drug and delivered it in a way
that’s user-friendly. An ER doctor could never have used it
before,” Palmer said.

Yet because so many other opioids already exist, Dsuvia is
unnecessary, several physicians said. The benefits of a
single-use package, and of a new way of giving the painkiller,
aren’t particularly significant, they said.

“I agree that patients need to be treated for pain, but I don’t
think this solves that problem except maybe in a very incremental
way,”
Jeremy Samuel Faust, an attending physician in the department
of emergency medicine at Brigham and Women’s Hospital in Boston
and an instructor at Harvard Medical School, told Business
Insider.

“It’s not a game-changer,” he added.

‘Like engineering overkill’

AcelRx

Because of the wide range of available opioids and the frequency
with which they are given, medical dosing errors do happen.
Dosing errors include situations where the wrong type or dose of
medication is given to a patient and they’re either under-treated
for their pain or given too much medication, potentially injuring
or killing them.

Good data on just how frequent these errors are and how often
they harm or even kill patients is lacking. A
2012 report authored by the nonprofit healthcare
accreditation organization the Joint Commission suggested that
while the errors were common, they could not determine how
frequently they were fatal. 

“Of the opioid-related adverse drug events — including deaths —
that occurred in hospitals and were reported to The Joint
Commission’s Sentinel Event database (2004-2011), 47% were wrong
dose medication errors,” the report read.

If the main problem with current opioids is that they are easily
mixed up, physicians say there are much simpler solutions than
introducing a more potent oral opioid.

“If the real concern is the wrong bottle, why not color-code the
bottles?” asked Ernest
Rasyidi, a psychiatrist in the emergency clinician decision
unit at St. Joseph Hospital in Orange, California.

“There are plenty of low-cost solutions out there if this is a
systems problem,” Rasyidi said. “But this would be a very
complicated and round-about way of solving that issue. It’s like
engineering overkill.”

Faust agreed.

“Medication errors are a problem but I wouldn’t say that the
solution is adding another medication that’s packaged
differently. Why not better labeling?”

But Palmer believes Dsuvia solves a problem that isn’t currently
being addressed.

“The future is Dsuvia. It’s not starting an IV and giving a
liquid that even has the remotest possibility of being confused
for another drug,” she said.

She compared the need for new and better opioids to the car
industry.

“They’re dangerous but they’re necessary,” Palmer said.

“When you have something dangerous but necessary, you have to
innovate.”