FDA controversially approves potent opioid up to ten times stronger than fentanyl

Despite voices of criticism, the FDA has opted to approve AcelRX’s Dsuvia (sufentanil), an opioid medication said to be five to ten times stronger than fentanyl, for the management of severe, acute pain at a time when the US teeters amidst an addiction epidemic which has claimed the lives of over 71,000 throughout 2017.

The approval decision comes after an advisory committee voted 10-3 in favour of recommending the drug, despite an FDA staff report released prior to the vote questioning its therapeutic benefit compared to other available treatments. Dsuvia was approved in June this year in Europe under the name Dzuveo, but this is AcelRx’s second attempt to push through the drug in the US after it was rejected in October last year.

The decision itself was based on Phase 3 data in which Dsuvia’s demonstrated "statistically greater summed pain intensity difference from baseline" over the study’s first 12 hours compared to placebo. This difference was shown to be superior within 15 minutes, with median meaningful pain relief achieved with just one dose.  Additionally, only around 22% of those taking Dsuvia took rescue medication within the first 12 hours of treatment, compared to 65% of those taking placebo.

"The FDA approval of Dsuvia is the culmination of nearly 15 years of research to improve the standard of care for managing acute pain in medically supervised settings," commented Dr Pamela Palmer, Co-Founder and Chief Medical Officer at AcelRx. "As an anaesthesiologist, I've seen the challenges that IV opioids pose to patients and providers, such as logistical delays in initiating IV lines, difficulty in accessing veins, and medication errors with injectable opioids. AcelRx was founded to develop a simple, effective, non-invasive analgesic option to enable healthcare professionals to rapidly manage their patients' acute pain."

Administered under the tongue as a single-dose 30mg tablet by a medical professional, the drug promises relief of intense pain within 30 minutes, and is designed to be used on the battlefield or in emergency medical situations where an IV is not suitable.

However, concerns have been raised that the drug’s small, intensely concentrated formulation makes it a prime candidate for smuggling on the illegal drug market, further fuelling the ongoing opioid crisis.

Coinciding with the approval, FDA Commissioner Scott Gottlieb moved to assuage these fears. Saying in a 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."

He continued: "I believe that we should consider whether we should be doing more to evaluate each candidate opioid, not just as an independent review decision, but rather also to consider each novel opioid drug in the context of the overall therapeutic armamentarium that's available to patients and providers."

However, Dr Raeford Brown, Chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and a professor of anesthesiology and paediatrics at the University of Kentucky, was unconvinced, remarking in a statement: "I am very disappointed with the decision of the agency to approve Dsuvia. As I discussed with representatives of the agency today, neither the lack of efficacy data nor the sponsor’s response to safety concerns, have been answered.

"Clearly the issue of the safety of the public is not important to the commissioner, despite his attempts to obfuscate and misdirect."

Launch of the drug is scheduled for the first quarter of 2019.

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