Cipla’s step-down associate firm Avenue Therapeutics has failed to get approval from the US Food and Drug Administration (FDA) for IV tramadol as an alternative for reducing the use of conventional opioids in patients with acute pain.
Avenue Therapeutics had been issued a second complete response letter (CRL) pertaining to its new drug application (NDA) seeking approval for IV tramadol.
As per the CRL, the delayed and unpredictable onset of analgesia with IV tramadol does not underpin its benefit as a monotherapy for the treatment of acute pain.
The FDA also stated in the CRL that there is inadequate information to support that IV tramadol in combination with other analgesics is safe and also effective for the intended patient population.
The regulator did not identify any chemistry, manufacturing, and controls (CMC) issues in the CRL, said Avenue Therapeutics.
The specialty pharma company said that it does not agree with the regulator’s interpretation of the data in the NDA and plans to continue to seek regulatory approval for IV tramadol.
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