FDA Sends Avenue Therapeutics a Complete Response Letter Over Nonopioid Painkiller
The FDA has issued a Complete Response Letter to Avenue Therapeutics for its intravenous (IV) tramadol, declining to approve the nonopioid painkiller’s New Drug Application (NDA).
The agency said the IV formulation offered delayed and unpredictable pain relief and it could not support its benefit as a monotherapy for patients with acute pain. The FDA also said there wasn’t enough information to demonstrate that the drug was safe and effective for the intended patient population when combined with other painkillers.
The FDA’s decision arrives more than two months after its target action date of April 12. The agency had previously sent Avenue a Complete Response Letter over IV tramadol in October, with Avenue later submitting a revised NDA.
The N.Y.-based drugmaker said it will continue seeking approval for IV tramadol, adding that the agency did not cite any problems with chemistry, manufacturing and controls in its letter.