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Biotech Stocks Facing FDA Decision In October 2020

Avenue Therapeutics
Avenue Therapeutics

Avenue Therapeutics Inc.’s (ATXI) New Drug Application for intravenous (IV) Tramadol is under FDA review, with a decision expected on October 10, 2020.

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.

If approved, 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.

Avenue Therapeutics is a majority controlled subsidiary company of Fortress Biotech (FBIO).

ATXI closed Friday’s (Sep.25, 2020) trading at $10.92, up 0.09%.