Intramuscular Injectable Generic Analgesic Ketamine for use in an FDA Approved Emergency Use Authorization

The purpose of this RFI is to address the USAMMDA WPAC requirement for the development of analgesics for acute severe pain associated with battlefield injuries. The WPAC PMO of USAMMDA is conducting market research to determine the feasibility of securing a manufacturer for the procurement of generic ready-to-inject ketamine for intramuscular injection (IM) for analgesia. No other route of ketamine administration or combination product(s), including autoinjectors, will be considered.

In addition, the injectable ketamine must be available for immediate purchase from the open market. The generic ketamine will be used to gain an FDA approved Emergency Use Authorization (EUA) for analgesic ketamine with a subsequent proposed label indication for acute pain via the 505(b)(2) pathway. The sponsor for the EUA will be the Department of Defense (DoD).

The analgesic ketamine EUA will allow the DoD to formulate policies on analgesic ketamine use which is expected to result in a large demand for ketamine throughout the Joint Service Military Health System.