Avenue Therapeutics Inc (NASDAQ:ATXI) in a statement announced that the group has received Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA). Through the second CRL, the company is hoping that it will receive a nod for usage of IV tramadol.
In the CRL, the group stated that a delay and the unpredictable onset of analgesia with IV tramadol would not support it as a monotherapy used to treat patients suffering from conditions like acute pain. Furthermore, it is alleged that there is not enough information and literature to support the claim that IV tramadol, when combined with other analgesics, is safe and can be used to treat the respective set of patients.
On the other hand, the FDA failed to identify and highlight any issue with the Chemistry Manufacturing, and Controls (CMC) in the CRL. In this backdrop, Avenue Therapeutics Inc is at loggerheads with the FDA’s narrative of data present in the NDA. Nevertheless, the group also expressed that it will not give up on its effort to obtain regulatory approval for IV tramadol. A source from the specialty pharmaceutical company shared that the group will continue to work on its mission to develop IV tramadol.
Market Reaction:
On Friday, ATXI stock moved up 2% at $1.52 with more than 23k shares, compared to its average volume of 98k shares. The stock has moved within a range of $1.4900 – 1.5300 after opening the trade at $1.51.
