The US Food and Drug Administration has approved a potent new opioid medication that is up to 10 times stronger than fentanyl, according to The New York Times. While the drug was approved with a 10 to 3 vote by the advisory committee, the panel’s chairman was vocally opposed to its approval. Dr. Raeford Brown had written a letter calling on FDA officials to reject the drug, saying it could be easily abused.
Called Dsuvia, the drug is a tablet version of sufentanil, a synthetic opioid that has been in use for decades in intravenous and epidural form.
“I predict that we will encounter diversion, abuse and death within the early months of its availability on the market,” Dr. Brown said in his letter, written in conjuction with leaders of Public Citizen, a consumer advocacy group. He called Dsuvia “an extremely divertible drug.”
Brown is an anesthesiology professor at the University of Kentucky.
After the drug was approved Friday, FDA commissioner Scott Gottlieb defended the decision in a written statement:
“There are very tight restrictions being placed on the distribution and use of this product. We’ve learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis. We’ve applied those hard lessons as part of the steps we’re taking to address safety concerns for Dsuvia.”
Dsuvia will not be dispensed at pharmacies. Instead, it will only be available to providers in medical settings. Defenders of Dsuvia say it will fill a gap in treatment options, since it dissolves under the tongue, allowing it to take effect more quickly than pills that are swallowed. Gottlieb points out this will be an important new option for soldiers on the battlefield with no access to intravenous drugs.
Yet Brown and other critics say the agency bypassed its usual vetting process, and that the potency of the drug paired with its small size, at just 3 millimeters wide, makes it ideal to be sold or misused. They also argue it hasn’t been as effective or fast-acting as expected in testing.
“We have worked very diligently over the last three or four years to try to improve the public health, to reduce the number of potent opioids on the street. I don’t think this is going to help us in any way,” Brown said.
The drug will be produced by AcelRX, which hopes to put Dsuvia in hospitals as soon as next year. They project $1.1 billion in annual sales.
Referring to the ongoing nationwide opioid crisis, Brown admitted:
“I have strong feelings about the opioid crisis, as someone who lives in the Commonwealth of Kentucky, where we continue to have people die.”