- Avenue Therapeutics Inc ATXI received the official meeting minutes from the FDA regarding a meeting conducted for IV Tramadol in combination with other opioid analgesics to manage moderate-to-moderately severe pain.
- At the meeting, Avenue presented a study design for a single safety clinical trial that the company believes could address the concerns regarding risks related to opioid stacking.
- The FDA stated that the proposed study design appears reasonable and agreed with the expectation that additional feedback would be provided to Avenue upon review of a more detailed study protocol.
- The company intends to submit a detailed study protocol that could form the basis for submitting a complete response to the second Complete Response Letter for IV Tramadol.
- In February, FDA’s adComm said that Avenue Therapeutics submitted insufficient data.
- In June 2021, Avenue…
