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To address the first concern, the company lowered the maximum daily dose from 24 to 12 tablets and provided new safety data. To address the second concern, the company modified directions for use and carried out another study.
The new results showed that although the rate of opioid-related gastrointestinal adverse effects were generally higher in patients who took the maximum daily dose, the rate of other adverse effects were comparable between higher- and lower-dose groups.
The company emphasized that the product is not intended for home use and would only be available in doctor’s offices or in hospitals. It would not be sold at drugstores even with a prescription.
“The availability of a single-dose, noninvasive opioid, like Dsuvia, could significantly improve my ability to effectively, efficiently and safely alleviate acute pain experienced by my patients,” David Leiman, MD, a clinical assistant professor of surgery at the University of Texas at Houston, says in the company news release.
Diversion, Abuse, Death
In Brown’s view, though, sufentanil poses substantial risks for respiratory failure, abuse, and death.
Right now, the drug is restricted to IV use by professionals such as anesthesiologists who have some understanding of its dangers, he says. “It’s really a drug used in the operating room where there are airway management experts available.”
But outside that environment, doctors across the United States have little experience with this drug, Brown says.
Sufentanil is “extremely divertible,” he says. “We have learned a hard lesson in the US that if you put a drug on the market, it will be diverted, and if it’s diverted, people will die.”
The drug is so potent that people “will become rapidly addicted to it” and may be in danger of overdosing or “rapidly transitioning” to heroin if it’s not available, Brown says.
For the drug to be restricted to closely controlled settings, prescriber education needs to be guaranteed, something that Brown says is not the case. All too often, he has seen the same scenario “pan out” with other opioids over the years.
“There’s the suggestion that a drug will be fine because it will be closely monitored, and then it’s not. The FDA realistically does not have the statutory authority, or the will, to go after people who are using these drugs inappropriately,” he says.
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