As America’s opioid crisis worsens, a powerful new opioid painkiller is poised to receive government approval. The Federal Drug Administration is considering a New Drug Application for a new form of sufentanil, a potent opioid that the Drug Enforcement Administration says is ten times more potent than fentanyl and 1,000 times more potent than morphine. On October 12, the FDA Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) voted 10-3 in favor of advising the FDA to approve the drug.
Sufentanil injections have been used by doctors in hospitals for about 20 years, but the new formulation, made by AcelRx under the brand name DSUVIA, uses a single-use plunger to deliver sufentanil in a tiny pill that dissolves under the tongue. The 10-3 vote margin suggests this vote will pass but belies the controversy surrounding this drug. Even the head of the AADPAC, Raeford Brown, M.D., is strongly opposed.
Brown, a professor of anesthesiology and pediatrics at the University of Kentucky, warned in a statement that there simply isn’t enough evidence to suggest that the benefit of putting another opioid on the market is justified by the risk it could pose to public health:
Sufentanil is a case in point. It has been used as an intravenous (IV) agent by clinicians only in hospital settings for more than twenty years. It is a very potent opioid with substantial risks of respiratory depression, diversion, abuse, and death. It is so potent that abusers of this intravenous formulation often die when they inject the first dose; I have witnessed this in resuscitating physicians, medical students, technicians, and other health care providers, some successfully, as a part of my duties as a clinician in a major academic medical center. Because it is so potent, the dosing volume, whether in the IV formulation or the sublingual form, can be quite small. It is thus an extremely divertible drug, and I predict that we will encounter diversion, abuse, and death within the early months of its availability on the market.
Can Diversion Be Avoided?
The possibility of diversion — when a prescription drug makes its way into the hands of people without prescriptions — is one of the major concerns about putting new opioid drugs on the market. The ongoing opioid overdose crisis is fueled in large part by fentanyl varieties, so a new type of fentanyl on the market doesn’t come across as good news for public health.
But despite the drug’s obviously bad optics, AcelRx and the FDA maintain that DSUVIA would only be used in hospitals by physicians and is therefore not a threat for diversion.
Kevin Kunzmann, an associate editor at MD Magazine, supports the notion that DSUVIA would be safely confined within the walls of hospitals. He wrote on Friday that major news outlets “seemed to have lost crucial details when writing their headlines,” pointing out that risks of abuse are overblown since DSUVIA would be used in hospitals under close doctor supervision.
The Risks Are High
A 2008 paper in the journal Anesthesiology showed that sufentanil was one of the drugs that anesthesiologists most frequently said they used when entering treatment for addiction. In other words, even the doctors who are charged with safely dispensing the substance have not been immune to the temptation to misuse it. The consequences can be fatal: A 2005 paper in the journal Anesthesia and Analgesia showed that 19 percent of anesthesiology training programs in the US had seen at least one resident die before receiving drug treatment between 1991 and 2001.
Brown and Public Citizen take issue with the fact that the FDA and AADPAC don’t seem to have grappled realistically with these risks or with the risk that DSUVIA will get diverted outside of hospitals. They cite the decision to exclude the FDA’s Drug Safety and Risk Management Advisory Committee from the October 12 meeting as evidence that the FDA plans to move forward with the drug’s approval, regardless of the risks.
“The FDA appears to have made a deliberate decision to avoid including the full DSRMAC in the review of sublingual sufentanil tablets in order to tilt [the] outcome of the AADPAC in favor of approval,” wrote the heads of Public Citizen’s Health Research Group, calling the exclusion “inexplicable.”
FDA spokespeople declined to comment on the DSUVIA approval process or on Brown’s statement of opposition, saying only that, “Although advisory committees provide recommendations to the agency, the FDA makes the final decisions.”
The FDA is expected to make a decision about AcelRx’s New Drug Application by November 3.