Avenue Therapeutics Inc.’s (ATXI) New Drug Application for intravenous (IV) Tramadol, which was turned down by the FDA last October, is trying for a second time to secure approval, and a decision is expected on April 12, 2021.IV Tramadol is proposed for the management of moderate to moderately severe pain in adults in a medically supervised health care setting.Tramadol in oral tablet formulation was approved by the FDA way back in 1995. Oral Tramadol is a Schedule IV drug and is widely prescribed in the U.S.Depending upon a drug's acceptable medical use and its abuse or dependency potential, it is classified into 5 distinct categories or schedules. Schedule I drugs have high abuse potential and no accepted medical use, while Schedule V drugs have very low abuse/dependency potential.The FDA declined to approve IV Tramadol last October stating that although the phase III clinical trials demonstrated statistically significant outcomes for all of the primary and many secondary endpoints, the drug candidate, intended to treat patients in acute pain who require an opioid, is not safe for the intended patient population.IV Tramadol could be a potential alternative capable of reducing the use of conventional opioids as well as filling a gap between IV acetaminophen/NSAIDs and IV conventional narcotics in the acute pain space, according to Lucy Lu, Avenue’s President and Chief Executive Officer.If approved, IV Tramadol will be the only intravenous Schedule IV opioid in the U.S.Avenue Therapeutics is a majority controlled subsidiary company of Fortress Biotech (FBIO).ATXI closed Friday’s (Mar.26, 2021) trading at $5.88, down 2.33%.