Sufentanyl approved in the USA – when too much opioid is barely enough…

Despite the opioid crisis that it current in the USA, the FDA has recently approved a sublingual dosage form of sufentanyl, a drug with opioid effects an order of magnitude more powerful than fentanyl, which itself is implicated in many opioid-related deaths. Intended as a substitute for parenteral opioids, the product has been criticised on the basis of easy diversion and abuse potential. The sponsor company filed documentation that asserts an unmet market need: “While there are a variety of choices for managing moderate-to-severe acute pain, there is still a clinical need for a noninvasive, rapidly acting, opioid analgesic that does not have active metabolites, has an appropriate and predictable duration of action, avoids the need to swallow pills, and has been developed for and tested in opioid-naïve patients.” Read the FDA briefing document here.