Avenue Therapeutics, Inc. previously disclosed that, on March 18, 2022, the Company received an Appeal Denied Letter from the Office of New Drugs of the Food and Drug Administration (the “FDA”) in response to a formal dispute resolution request submitted by the Company with the Office of Neuroscience of the FDA on July 27, 2021. The Letter recommended that as a path forward, the Company “request a meeting with the Division regarding additional studies that can better assess the appropriate clinical setting for the administration of tramadol IV and to evaluate the potential risk for opioid stacking”. On August 31, 2022, the Company disclosed that, on June 17, 2022, following the receipt of the Letter, the Company submitted a Type A Meeting Request and related briefing documents to the FDA.

The meeting was granted by the Division of Anesthesia, Analgesia, and Addiction Products (“DAAAP”) on June 27, 2022, and scheduled for August 9, 2022. The Company submitted a briefing document presenting a study design that the Company believed has the potential to address the comments and deficiencies noted in the Letter and sought the DAAAP's guidance to refine the study design that would support a resubmission of a New Drug Application for the Company's current lead product candidate, intravenous Tramadol. The meeting on August 9, 2022 was a collaborative discussion on the study design and potential path forward.

The Company expects to receive official meeting minutes by mid-September and expects to evaluate further the potential to generate data supportive of an FDA approval.