Avenue Therapeutics Gets CRL for IV Tramadol
Avenue Therapeutics has a received a Complete Response Letter (CRL) from the FDA regarding its new drug application (NDA) for intravenous tramadol, meant for treating acute pain in adults.
In the CRL, the FDA said the drug is “not safe for the intended population” because it could lead to opioid “stacking,” as patients will need an additional opioid following treatment, increasing the risk of opioid-related adverse effects.
The agency also called for a validation to ensure that the product remains sterile in its final container. A validation was planned by year’s end, but the agency said it would need to be done before it would approve the NDA.
The drugmaker said it is seeking an immediate meeting with the FDA to discuss how to address the agency’s concerns.