FDA Approves New, Ultra-Potent Opioid Painkiller

Despite warnings from recovery advocates, physicians, and its own advisory committee, the Food and Drug Administration approved a new ultra-potent opioid painkiller that is 10 times stronger than Vicodin.

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The drug’s potency, as well as the timing of its release to the market, raised serious concerns.

Despite warnings from recovery advocates, physicians, and its own advisory committee, the Food and Drug Administration approved a new ultra-potent opioid painkiller that is 10 times stronger than Vicodin. The drug sufentanil is called Dsuvia and made by pharmaceutical company AcelRx. It is administered sublingually: it’s put under patients’ tongues, rather than injecting it or giving a pill to swallow.

The drug’s potency, as well as the timing of its release to the market, raised serious concerns. Dr. Palmer MacKie, assistant professor at the Indiana University School of Medicine and director of the Eskenazi Health Integrative Pain Program in Indianapolis said, “We may find a niche for [Dsuvia] but it’s not like we need it, and for sure, at some level, it’s going to be diverted. Do we really want an opportunity to divert another medicine?”

The answer, for many, is no. Dsuvia is allegedly designed for special circumstances where extreme pain management in a short period of time is critical. AcelRx cited two situations where Dsuvia would be appropriate: battlefield medicine, and for morbidly obese pain emergency room patients. The drug will not be dispensed in pharmacies, the company says. Instead, health care providers will only be able to use it in medical centers.

Experts say that limiting Dsuvia’s use to medical settings won’t prevent misuse, and its potency and design are unsafe. Without strict guidelines, the pharmaceutical market continues to create and push products that perpetuate and profit from the drug epidemic. Peter Jackson, co-founder of Advocates for the Reform of Prescription Opioids, told CBS News, “It’s like the wild west. The whole supply-side system is set up to perpetuate this massive unloading of opioid narcotics on the American public.”

Addiction experts’ concerns were not heard, and drug safety experts were excluded from the decision to approve Dsuvia. Dr. Raeford Brown, an anesthesiologist at the University of Kentucky, chairs the FDA committee that voted for Dsuvia’s approval. He said, “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 [Dsuvia] is going to help us in any way. I have strong feelings about the opioid crisis, as someone who lives in the Commonwealth of Kentucky, where we continue to have people die.”

Other experts pointed out that it’s extremely naive to assume Dsuvia won’t be diverted at some level—likely, not by patients. Although AcelRx claims the drug fills a “niche need,” it’s questionable whether it’s necessary at all. Many have voiced concerns that the minor benefits of Dsuvia are significantly outweighed by its dangers.

Dr. Sidney Wolfe, senior adviser to Public Citizen’s Health Research Group, said that Dsuvia does not meet a crucial need. He said, “[Dsuvia] is not unique at all.”

He told NPR that Dsuvia wasn’t adequately tested in emergency settings, and that in tests, pain relief with Dsuvia was slow. In two of the company’s studies, Dsuvia patients only felt “meaningful” pain relief at 54 minutes and 78 minutes.

Warnings about the drug—which included a letter to the FDA signed by four Senators—were disregarded. The FDA pushed Dsuvia through the approval process, cutting corners and excluding certain members of the drug safety committee.

AcelRx projects $1.1 billion in annual sales, and hopes to have its product in hospitals early next year.

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