November 04, 2018
The U.S. Food and Drug Administration approved a new opioid drug used to manage pain on Friday despite warnings that it would likely be abused.
The drug is called Dsuvia and is made by AcelRx Pharmaceuticals Inc. as a tablet in a single-dose, prefilled applicator to be administered under the tongue by health care providers to patients in settings like hospitals, surgical centers and emergency rooms, according to a company release.
The FDA's approval has stirred up some controversy amid the ongoing opioid crisis, as its intravenous and epidural use has already been used in the U.S. since 1984. According to the New York Times, the drug is 10 times stronger than fentanyl.
Last year, overdose deaths spiked up to 40,000 last year, with more than 30,000 from fentanyl and other synthetic opioids, the Times reported.
After the final approval on Friday FDA Commissioner Scott Gottlieb addressed concerns in a statement.
"There are very tight restrictions being placed on the distribution and use of this product," Gottlieb wrote. "We’ve learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis."
He reiterated that the drug will only be administered by health care providers. And, AcelRx announced it would be following a safety program that would focus on risk evaluation and mitigation strategy.
You can read the entire statement here.
Dsuvia is expected to be on the market by early next year.