- Avenue Therapeutics Inc ATXI has received a second Complete Response Letter from the FDA regarding its marketing application seeking approval for IV tramadol.
- Citing delayed and unpredictable onset of analgesia with tramadol, the agency said that the treatment does not support its benefit as a monotherapy to treat patients in acute pain.
- Also, there is insufficient information supporting the safety and effectiveness of tramadol in combination with other analgesics.
- The FDA did not identify any Chemistry, Manufacturing, and Controls issues.
- Avenue disagrees with the FDA's interpretation of the data and intends to pursue regulatory approval for IV tramadol.
- Price Action: ATXI shares dropped 4.8% at $4.01 before the trading was halted. To resume at 7:30 a.m. ET.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in
