Avenue Therapeutics Inc. (ATXI) shares fell -45.84% to $2.28 in premarket trade today. Last trading session, Avenue stock has fallen -3.44% to $4.21. ATXI stock retreated even more -8.17% in the last five days but gained 2.93% over the past month. Before market open this morning, ATXI stock fell after the US Food and Drug Administration (“FDA”) rejected its new drug application (NDA).

The NDA was for which drug?

The mission of Avenue Therapeutics is to develop IV tramadol. US patients suffering from acute pain may be able to decrease their reliance on conventional opioids with IV tramadol. Avenue was formed by the Fortress Biotech Corporation in New York City.

Today, Avenue announced that the FDA has sent a second Complete Response Letter (“CRL”) in connection with its application for approval of IV tramadol.

• The CRL concluded that IV tramadol’s delayed and unpredictable onset of analgesia does not support its use as a monotherapy to treat acute pain.
• Furthermore, the CRL stated that there is not enough information to support the combination of ATXI’s painkiller with other analgesics being safe and effective for the intended population.
• In this CRL, the FDA highlighted no Chemistry, Manufacturing, and Controls (“CMC”) issues in ATXI’s candidate.
• An October decision by the health regulator had rejected approval for the ATXI’s painkiller due to its unsuitability for the intended users.

ATXI’s stance:

The FDA’s interpretation of the data in the NDA is not consistent with Avenue (ATXI)’s position, said the company in its statement. ATXI once again committed to continue seeking regulatory approval for IV tramadol.