On October 1, 2021, Trevena, Inc. (the “Company”) received verbal notification from the U.S. Food and Drug Administration (the “FDA”) that the Company's submitted Investigational New Drug (“IND”) application for TRV045 will be placed on hold to address certain Phase 1 study design elements. In accordance with standard practice, the FDA will issue a letter within the next 30 days documenting the items that need to be addressed. Once the Company receives this letter, it expects to respond to the FDA quickly.