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 IV Tramadol.  

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 Anesthesia, Analgesia and Addiction Products (DAAAP).

“Our meeting with the FDA was very productive and led to agreement on many of the outstanding items regarding the proposed study protocol that would assess the risk of opioid-induced respiratory depression related to opioid stacking on IV Tramadol relative to an approved opioid analgesic,” said Alexandra MacLean, M.D., Avenue’s Chief Executive Officer. “We are finalizing the protocol based on the FDA’s feedback and look forward to the continued collaborative discussions with the FDA with the goal of partnering or initiating a Phase 3 safety study this year to assess the risk of opioid-induced respiratory depression related to opioid stacking on IV Tramadol relative to an approved opioid analgesic when treating post-operative pain. We expect that a positive study outcome could result in the approval of IV Tramadol. Additionally, we plan to provide updates on our other two programs later this year including the AJ201 clinical trial to treat spinal and bulbar muscular atrophy and the continued development of BAER-101 for epilepsy and acute anxiety. Avenue continues to stay true to its mission of developing impactful therapies to treat patients with rare and neurologic diseases, while generating shareholder value.”