Avenue Therapeutics (NASDAQ: ATXI) (“Avenue”) is a company that develops intravenous Tramadol IV for the United States market, and it recently received its second CRL (Complete Response Letter) from the FDA regarding its New Drug Application which requested approval for Tramadol IV.
The Complete Response Letter stated that the unpredictable and delayed analgesia onset with Tramadol IV doesn’t support its effectiveness as a monotherapy solution to treat people suffering from acute pain. There’s simply not enough data to support whether the combination of Tramadol IV and other analgesics is effective and safe for the intended patients. The FDA didn’t identify any CMC (Chemistry, Manufacturing, and Controls) problems in the CRL
Avenue Therapeutics doesn’t agree with the way the data was interpreted by the FDA in the NDA and will continue to seek regulatory approval for this new drug.
About Avenue Therapeutics
Avenue Therepeutics Inc. is a specialty pharma corporation whose main objective is developing the Tramadol IV drug. This drug is a potential alternative to conventional opioids and can help treat people in the U.S suffering from acute pain. Avenue Therapeutics’ headquarters are located in New York City, and its founders are Fortress Biotech (NASDAQ: FBIO).
About Fortress Biotech
Fortress Biotech is a biopharmaceutical corporation ranked in the 2020 Technology Fast 500 and Deloitte’s 2019 annual rankings. The company concentrates on developing, acquiring, and commercializing high-potential development-stage drugs. The company already has around seven prescription pharma products and more than 25 programs in the development stage. The products under development span across six large markets, including gene therapy, rare diseases, and oncology. Fortress’s diversified pipeline advances via a streamlined operating system that encourages efficient drug development. Not many companies out there can do this better than them.