The Anesthetic and Analgesic Drug Products Advisory (AADPAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) will discuss new drug application (NDA) 213231, for tramadol hydrochloride injection, submitted by Avenue Therapeutics, Inc., for the management of moderate to moderately severe pain in adults in a medically supervised healthcare setting. The committees will also discuss the clinical relevance of tramadol hydrochloride injection, an opioid intended for management of acute pain in a medically supervised healthcare setting, when its onset of action is delayed, and its proposed dosing is a fixed-dosing regimen.