Avenue Therapeutics, focused on the development of intravenous (IV) tramadol for the US market, announced that it has received a second Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding its New Drug Application (NDA) seeking approval for IV tramadol.
The CRL stated that the delayed and unpredictable onset of analgesia with IV tramadol does not support its benefit as a monotherapy to treat patients in acute pain, and there is insufficient information to support that IV tramadol in combination with other analgesics is safe and effective for the intended patient population. The FDA did not identify any Chemistry, Manufacturing and Controls (CMC) issues in this CRL.
A company statement said, “Avenue disagrees with the FDA’s interpretation of the data in the NDA and intends to continue to pursue regulatory approval for IV tramadol.”
Avenue Therapeutics is Cipla’s step-down associate company in the US.