Drugs

Avenue Therapeutics Plans IV Tramadol Resubmission

Avenue Therapeutics says it has had a Type C meeting with FDA to map out a plan for resubmitting a twice-rejected NDA for intravenous (IV) tramadol for treating post-operative pain. “The purpose of this meeting was to discuss and reach agreement with the FDA on the proposed study protocol that would assess the risk of opioid-induced respiratory depression related to opioid stacking on IV tramadol compared to IV morphine,” the company says.

FDA 6/2021 issued Avenue Therapeutics a second complete response letter on the NDA. The letter said 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 was insufficient information to support the company’s claim that IV tramadol in combination with other analgesics was safe and effective for the intended patient population. The first complete response letter was issued 10/2020 due to safety concerns (see earlier story).

Avenue says the minutes from the recent meeting “indicate that the FDA and Avenue Therapeutics are in agreement with a majority of the proposed protocol items and are in active discussion about remaining open items. The minutes indicate that the FDA also agrees that a successful study will support the submission of a complete response to the second Complete Response Letter for IV tramadol pending final agreement on a statistical analysis plan and a full review of the submitted data in the complete response as well as concurrence from the Division of Anesthesia, Analgesia and Addiction Products (DAAAP).”

Avenue further says it is finalizing the protocol based on the FDA’s feedback and expects “continued collaborative discussions” with the agency to agree on a Phase 3 safety study this year to “assess the risk of opioid-induced respiratory depression related to opioid stacking on IV tramadol relative to an approved opioid analgesic when treating post-operative pain.”

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