Avenue Therapeutics, Inc. announced that it has received official meeting minutes from the Type C meeting with the U.S. Food and Drug Administration ("FDA") conducted on March 9, 2023, regarding the development of intravenous ("IV") Tramadol for the treatment of post-operative pain. The purpose of this meeting was to discuss and reach agreement with the FDA on the proposed study protocol that would assess the risk of opioid-induced respiratory depression related to opioid stacking on IV Tramadol compared to IV morphine. As disclosed in September 2022, Avenue received meeting minutes from the FDA regarding a Type A meeting conducted on August 9, 2022, for IV Tramadol.

At that meeting, Avenue presented a study design for a single safety clinical trial that the Company believes could address the concerns regarding risks related to opioid stacking and the FDA stated that the proposed study design appeared reasonable and agreed on various study design aspects with the expectation that additional feedback would be provided to Avenue upon review of a more detailed study protocol. Subsequent to the August 9 meeting, the Company incorporated the FDA's suggestions from the meeting minutes and submitted a Type C Meeting Request and a briefing book that included a detailed study protocol as the basis for further discussion with the FDA on the requirements for a complete response to the second Complete Response Letter for IVTramadol. The Type C meeting minutes from the FDA indicate that the FDA and Avenue Therapeutics are in agreement with a majority of the proposed protocol items and are in active discussion about remaining open items. The minutes indicate that the FDA also agrees that a successful study will support the submission of a complete response to the second complete Response Letter for IV Tramadol pending final agreement on a statistical analysis plan and a full review of the submitted data in the complete response as well as concurrence from the Division of Anesthes, Analgesia and Addiction Products (DAAAP).