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Avenue Therapeutics Inc. (ATXI) stock plunges in the pre-market trading. Here’s to know why?

Avenue Therapeutics Inc. (ATXI) stock gained by 3.64% at the last trading close whereas the ATXI stock price declines by 20.11% in the pre-market trading session. As of now, there is no recent news available about this up and down in ATXI share price. Avenue Therapeutics is a specialized pharmaceutical company whose goal is to improve IV tramadol for patients with acute pain in the United States as a possible alternative to traditional opioids. Fortress Biotech, Inc. created Avenue, which is based in New York City.

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Past Developments

On December 18, 2020, ATXI announced that Drug and Alcohol Dependency which is a peer-reviewed international journal dedicated to studies, reviews, commentaries, and policy analyses in the field of drug, alcohol, and tobacco usage and dependence, has released a paper titled “Tramadol Non-Medical Use in Four European Countries: A Comparative Study.”

The study’s aim is to learn more about tramadol misuse and abuse in countries where parenteral tramadol is accessible, which necessitates standardized measures of misuse behaviors and occurrence across countries. The study concluded that tramadol misuse and abuse are uncommon, both in terms of absolute numbers of cases and in contrast to other opioids, and that injection misuse is uncommon, despite the availability of intravenous tramadol formulations.

Also,

Avenue Therapeutics got a Complete Response Letter (CDL) from the US Food and Drug Administration (FDA) in October regarding its New Drug Application (NDA) for IV tramadol, the medicine used to treat acute pain in people who need opioids. The FDA was concerned because the drug did not appear to be safe for its intended market.

Avenue Therapeutics, on the other hand, did not abandon IV tramadol. They highly stood behind the safety data in their NDA and the overall approvability of IV tramadol. On December 17, 2021, ATXI announced that following a recent meeting with the FDA, it would refile an NDA for IV tramadol to the FDA in February 2021, assuming no setbacks related to the ongoing COVID-19 pandemic.

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