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# Advisory Committee to Hear Avenue Dispute Resolution
- URL: https://www.fdaweb.com/advisory-committee-to-hear-avenue-dispute-resolution/
- Published: 2021-10-25T12:00:00.000Z
- Updated: 2026-09-14T17:20:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150430

Responding to a dispute resolution request, CDER’s Office of New Drugs has told Avenue Therapeutics that additional input is needed and an advisory committee meeting will be convened to review issues on its twice-rejected intravenous tramadol NDA, indicated for treating pain. After the joint Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management Advisory Committees offer their input, FDA has committed to provide a response to the dispute resolution request within 30 calendar days, according to the company.

In June, FDA issued Avenue a second complete response letter on its NDA, saying 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 is insufficient information to support the company’s claim that IV tramadol in combination with other analgesics is safe and effective for the intended patient population.

The first complete response letter was issued 10/2020 due to safety concerns. That FDA letter told the company that while its Phase 3 clinical trials demonstrated statistically significant outcomes for all of the primary and many secondary endpoints, the agency had determined that it could not approve the application in its present form for the same reason, Avenue said at the time. Specifically, if a patient requires an analgesic between the first dose of IV tramadol and the onset of analgesia, a rescue analgesic would be needed, the agency reportedly told the company. FDA was further concerned that the likely choice would be another opioid, which would result in opioid “stacking” and increase the likelihood of opioid-related adverse effects.