The Food and Drug Administration on Friday approved the controversial opioid Dsuvia to treat pain amid a scourge of opioid addiction and death in the U.S.
The latest version of the drug, which uses the chemical sufentil, comes as a tablet that dissolves under the tongue. Sufentil, which prior to Friday was approved only as an injection, is the most powerful opioid on the market and is 10 times more potent than fentanyl, the drug behind the vast majority of overdose deaths.
The approval comes at a time when the Trump administration is working to fight back against the crisis, tied to overdoses from prescription painkillers, heroin and fentanyl. It also comes just over a year after the FDA asked Endo Pharmaceuticals to remove its Opana ER drug from shelves.
“There are very tight restrictions being placed on the distribution and use of this product,” FDA Commissioner Scott Gottlieb wrote in a blog post. “We’ve learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis. We’ve applied those hard lessons as part of the steps we’re taking to address safety concerns for Dsuvia.”
Dsuvia is manufactured by California-based pharmaceutical company AcelRx.
Gottlieb explained the agency’s decision to approve the medication by saying that in certain circumstances people in pain are not able to swallow pills and can’t receive pain medication through an IV. Doctors won’t be allowed to prescribe the medication for patients to take at home, and it won’t be stocked in pharmacies. Patients will not be allowed to take it for more than 72 hours.
“The medicine is restricted to use in certified medically-supervised healthcare settings — such as hospitals, surgical centers, and emergency departments — for administration by a healthcare professional,” Gottlieb said.
He explained that the Department of Defense took interest in the medication for possible use on the battlefield, and went on to detail the FDA’s methods for deciding whether to approve opioids. For instance, the agency asks how the drug benefits public health by adding something to pain treatment that isn’t already available, and regulators decide whether the drug creates more risks for being diverted outside the system and used illegally.
He concluded that he believes the “unique aspects of Dsuvia, including those that make this drug a high priority for the Pentagon, differentiate this new formulation.”
Congress and the Trump administration has been working to battle the opioid crisis, which claimed the lives of more than 40,000 people in 2017. Of these deaths, 30,000 were tied to illicit fentanyl, a type of opioid that has been mixed with heroin or cocaine without a drug user’s knowledge.
Public health experts widely view the FDA’s approval of the opioid OxyContin in the 1990s as a major factor in the current crisis. Patients were improperly prescribed the drugs and developed dependence, and sought heroin instead, which affects the brain in a similar way and is inexpensive and more easily available.
Dsuvia, which comes in a single dose, will carry a black-box warning, the highest safety warning designation from the FDA. The label will warn patients and doctors that the drug carries high risk of abuse that can lead to overdose and death.
“We won’t sidestep what I believe is the real underlying source of discontent among the critics of this approval – the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction,” Gottlieb vowed.
