The FDA has approved the sublingual opioid sufentanil (Dsuvia) for moderate-to-severe acute pain. Sufentanil is already approved for intravenous and epidural use.
The drug is dispensed in a single-use applicator under medical supervision. The FDA said that its delivery mechanism makes it suited to situations where an IV cannot be placed and a patient cannot swallow.
Critics note the drug’s potential for abuse — it’s up to 10 times stronger than fentanyl. “I predict that we will encounter diversion, abuse, and death within the early months of its availability on the market,” Dr. Raeford Brown, chairman of the FDA’s advisory panel that voted to recommend the drug’s approval, wrote in a letter to the FDA. (Brown was unavailable for the committee vote.)
He adds: “Lack of historical ability of the FDA to enforce controls, the pharmacologic potency of the drug, and the ease with which this drug will be diverted are some of the reasons that I would never consider this product for marketing in the U.S. Sublingual sufentanil represents a danger to the general public health and will make our job of protecting Americans more difficult.”