WASHINGTON, DC — There are concerns over a new, even stronger opioid - and an FDA committee is recommending its approval.
Critics warn the new drug could be even more dangerous than oxycotin or fentanyl.
The question critics are asking is why would the FDA want to approve a stronger opioid right in the middle of a nationwide addiction crisis.
An DSUVIA is 500 times more powerful than morphine.
“It's 5 to 10 times more potent than fentanyl and it actually goes underneath your tongue,” said Public Citizen's Meena Aladdin.
The pill dissolves immediately when placed under the tongue by an applicator, meaning besides being powerful, it’s more fast-acting than other opioids.
The FDA drug advisory committee voted overwhelming 10 to 3 to recommend approving the drug Friday.
Critics like Aladdin said the strength and speed of DSUVIA make it attractive to addicts.
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“It is yet another drug on the market that could allow for another avenue for abuse,” Aladdin said.
The drug maker, Acelrx said in a statement: “We believe DSUVIA represents an important non-invasive acute pain management option with potential to significantly improve the current standard of care."
The FDA rejected approving the drug last year because of concerns it could get into the wrong hands.
So this time, the application included guidelines states that the drug must be administered by a trained healthcare professional.
This vote is not the final say. The FDA does not have to follow the committee’s recommendation, but usually does.
An FDA spokesman told Channel 2 Action News they don't comment on specific drugs pending approval.
Cox Media Group