Avenue Therapeutics announces FDA agreement on most protocol items for IV Tramadol safety study

AVENUE THERAPEUTICS, INC.

Received official meeting minutes from FDA Type C meeting on March 9, 2023, for IV Tramadol.
FDA and Avenue agree on majority of proposed protocol items for opioid-induced respiratory depression study vs IV morphine.
FDA agrees a successful study could support complete response to second Complete Response Letter for IV Tramadol.
Company expects to finalize protocol and potentially initiate Phase 3 safety study this year; also planning updates on AJ201 and BAER-101 programs.

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