Therapeutics

“Opioid Stacking” Concerns Lead FDA to Reject Avenue Therapeutics Drug

13 days ago   |   By Xconomy

An opioid that Avenue Therapeutics reformulated for treating post-surgical pain in hospital settings has been rejected by the FDA due to safety concerns. The Avenue drug is an intravenous formulation of tramadol, an opioid that first reached the US market 25 years ago in pill form. Now New York-based Avenue is trying to offer an alternative to painkillers used after surgical procedures, as well as an improvement over an intravenous formulation of tramadol that is already approved for use in Europe. But that improvement may have unwittingly led to the basis for the FDA rejection. In Europe...
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