U.S. FDA Declines to Approve Avenue Therapeutics Inc’s (NASDAQ: ATXI) Painkiller Again, Shares Drop

The U.S. Food and Drug Administration has once again declined to approve Avenue Therapeutics Inc’s (NASDAQ: ATXI) painkiller tramadol noting that it was not safe for the intended population. The announcement saw Avenue’s share drop by 5% in premarket trading. 

According to the FDA, intravenous (IV) tramadol showed delayed and the unpredictable onset of analgesia, which offsets its benefits as a monotherapy to treat patients with acute pain. The regulatory agency also cited lack of sufficient data to prove IV tramadol’s safety and effectiveness when used with other drugs. 

In its findings, the FDA did not identify any Chemistry, Manufacturing and Controls (“CMC”) issues. The drug maker says it disagrees with the interpretation of data and conclusion reached by the regulator and says it will continue to pursue the approval of the drug. 

The ATXI stock dropped -$0.23 to trade at $3.02 in the Monday pre-market session. Pre-markets are more volatile due to lower trading volumes.

H.C. Wainwright’s Ed Arce has maintained a Hold rating on ATXI stock. The share closed the Monday trading at $3.02 and has a market cap of $50.58 million with a P/E ratio of -14.50.  

The drug maker is developing IV tramadol as a potential alternative treatment to conventional opioids for people with acute pain in the U.S.

Avenue Therapeutics is a pharmaceutical company that specializes in acquiring, licensing, developing, and commercializing products that are used in intensive care units. The company develops and produces intravenous tramadol used in the treatment of moderate to moderately severe post-operative pain. Avenue has its headquarters in New York City and was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). 

In its Q1 2021 financial results, Fortress Biotech reported $291.5 million in consolidated cash, cash equivalents and restricted cash compared to $235.0 million reported in the previous quarter Q3 2020. During the quarter, net revenue amounted to $11.6 million.

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