Avenue Therapeutics Inc (NASDAQ: 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 Therapeutics received a second Complete Response Letter from the FDA regarding its marketing application seeking approval for IV tramadol.
Concurrently, Avenue Therapeutics announced that it would effect a 1-for-15 reverse stock split.
After the reverse stock split, the number of shares will be reduced from 22.7 million to 1.5 million.
Price Action: ATXI shares are down 29.5% at $4.65 during the premarket session on the last check Friday.
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