FDA Rejects Sugammadex And Exparel’s Expanded Usage
Earlier this year, the FDA nixed two drugs I was really looking forward to using in my training and/or practice.
Exparel (liposomal bupivacaine injection) had already been approved for bunionectomies and hemorrhoidectomies; however there was always a large push among regional anesthesiologists to use it for peripheral nerve blocks. Instead of having to localize a nerve bundle, thread a catheter, and infuse medications for several days to control post-operative pain, a single dose of Exparel could theoretically provide analgesia for several days without the need for a catheter and its associated risks (ie, catheter migration).
In 2013, Pacira Pharmaceuticals showed the safety and efficacy of Exparel in femoral nerve blocks following total knee arthroplasties (TKA) in phase 2 trials. Unfortunately, a more recent study using Exparel for intercostal nerve blocks in posterolateral thoracotomies did not show a reduction in cumulative pain scores. Ultimately, the FDA rejected Exparel for peripheral nerve blocks (for undisclosed reasons) prompting Pacira Pharmaceuticals’s CEO to announce the following:
“We are reviewing the contents of the CRL [complete response letter] and will work actively with the FDA to bring this important new indication to our core and growing business in infiltration.”
Bridion (sugammadex) had already been rejected twice by the FDA, and unfortunately faced its third rejection in March 2015 due to unresolved issues regarding a hypersensitivity study. Sugammadex encapsulates the nondepolarizing neuromuscular blockers Zemuron (rocuronium) and Norcuron (vecuronium) to promptly reverse the effects of paralysis. This would be a great alternative to the typical reversal agent (neostigmine), and I surmise it would also decrease the incidence of hyper-parasympathetic side effects (defecation, bradycardia) and post-operative weakness due to residual neuromuscular blockade.
Maybe one day Exparel and sugammadex will be pushed through the FDA’s stringent approval system!