Avenue Therapeutics Announces Regulatory Update Based On Type C Meeting With FDA

(RTTNews) - Avenue Therapeutics, Inc. (ATXI) Monday announced that it has received official meeting minutes from the Type C meeting with the U.S. Food and Drug Administration conducted on March 9, 2023, regarding the development of intravenous Tramadol for the treatment of post-operative pain. Following the news, shares of Avenue gained over 13% in after-hours trading session.

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.

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.