Avenue Therapeutics gets USFDA Complete Response Letter for IV Tramadol
Avenue disagrees with the FDA's interpretation of the data in the NDA and intends to continue to pursue regulatory approval for IV tramadol.
New York: Avenue Therapeutics has recently announced that the company has received a second Complete Response Letter ("CRL") from the U.S. Food and Drug Administration (USFDA) 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.
Avenue disagrees with the FDA's interpretation of the data in the NDA and intends to continue to pursue regulatory approval for IV tramadol.
Read also: Cipla associate Avenue Therapeutics gets regulatory update for intravenous tramadol
Headquartered in New York City and founded by Fortress Biotech, Inc, Avenue Therapeutics focuses on developing IV tramadol, a potential alternative that could reduce the use of conventional opioids, for patients suffering from acute pain in the U.S.
Read also: Avenue Therapeutics gets USFDA complete response letter for IV Tramadol
