This week, an FDA panel voted 10-3 to recommend approval for a new fast-acting form of an opioid drug that’s 10 times more potent than fentanyl.
Opioid overdose is the leading cause of death for Americans under the age of 50, with the sharpest increase in overdose deaths in 2017 connected to fentanyl and other synthetic opioids. Fentanyl — a highly regulated prescription drug that has been extensively counterfeited in recent years — is extremely dangerous because it’s much stronger than heroin, so drug users who either don’t realize the substance they’re using is cut with fentanyl, or don’t anticipate such a strong effect, can easily overdose.
The new drug, which would be marketed as Dsuvia, is a sublingual pill form of sufentanil, a synthetic opioid that is used for IV and epidural anesthesia. This new form of the drug is designed for fast relief from acute pain, and can start working in as little as 15 minutes. It’s meant to be used in medically supervised settings only, administered by health care professionals. This form of a strong painkiller that doesn’t require swallowing could be potentially valuable for patients who can’t swallow pills, and the single-dose form can help avoid dosage errors.
Of course, there is also the obvious concern about introducing yet another highly-potent opioid drug into the world that could be deadly if used incorrectly.
“I want to make patients safer after surgery from dosage errors, but not at the expense of people abusing it,” says Dr. Pamela Palmer, co-founder and chief medical officer of Dsuvia manufacturer AcelRx. She tells Rolling Stone that the way Dsuvia will be packaged and administered is designed to prevent abuse, as well as accidental dosage errors.
“IV liquids are fraught with dosing error after dosing error, but people still use them because they’re the only way to administer rapid pain relief,” Palmer says. A sublingual pill that works quickly but only comes in one fixed dose — as opposed to liquid morphine, for example, which comes in a range of dose sizes, all of which look the same — is a possible solution to that problem.
As for intentional abuse, Palmer says, the fact that the drug will only be available in hospitals makes abuse much less likely than with drugs like fentanyl and morphine, which are also available to outpatients.
“Sufentanil, remifentanil, alfentanil that are available only in hospital settings have a near-zero rate of outpatient abuse,” Palmer says. “It’s such an extremely tightly-run ship in hospitals. They have to account for every pill.”
She also says that AcelRx has a comprehensive Risk Evaluation and Mitigation Strategy (REMS) for Dsuvia, so they can track and intervene in any potential abuse.
Not everyone is convinced, however. Raeford E. Brown Jr., MD, a professor of anesthesiology and pediatrics at the University of Kentucky, who chairs the FDA committee but was not at the meeting where members voted on Dsuvia, is worried about the risks of abuse despite AcelRx’s best efforts to prevent it. (The committee vote isn’t binding, but is a step toward approval.)
“Sufentanil is a very potent opioid that is in a preparation that will be easily divertible. In the IV formulation, it has been a drug of abuse for health care providers. The proposed REMS that the Agency feels will protect public is untested and prior iterations have been less than successful,” he says. “Safety in important.”