14 June 2021 - Avenue Therapeutics today announced that it has received a second complete response letter from the U.S. FDA regarding its new drug application seeking approval for IV tramadol.

The CRL stated that the delayed and unpredictable onset of analgesia with intravenous tramadol does not support its benefit as a monotherapy to treat patients in acute pain, and there is insufficient information to support that intravenous tramadol in combination with other analgesics is safe and effective for the intended patient population.

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