FDA mulls approval for opioid 500 times stronger than morphine

Oct 22, 2018

An FDA committee has recommended approval of a new synthetic opioid much stronger than other pain killers on the market.  

The drug, Dsuvia, is made by AcelRx Pharmaceutical, who say it is designed to rapidly treat moderate-to-severe pain in cases of trauma or injury. Dsuvia is made from a synthetic opioid called sufentanil and is about 500 times stronger than morphine. 

AcelRx has argued that because Dsuvia is administered as a rapidly dissolving sublingual tablet that can take effect in as little as 15 minutes, it is a superior treatment to intravenous and epidural analgesics on the market. But critics counter that the drug will be easy to divert and could fuel America’s worsening opioid crisis. AcelRx maintains, however, that Dsuvia is not intended to treat chronic pain and would only be administered by medical professionals. 

The drug has been approved by the European Medical Agency under the name Dzuveo. Earlier this month, the FDA’s Anesthetic and Analgesics Drug Products Advisory Committee recommended the drug for approval after a 10-3 vote. 

Although the FDA is not required to follow the committee’s recommendation, the agency usually does. The FDA’s target action date for a final decision is Nov. 3. 

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