Avenue Therapeutics Inc. (NASDAQ: ATXI) has announced the outcome of its US FDA joint meeting of the Anaesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory on intravenous IV tramadol. The majority of the advisory committee members agreed that the company had not submitted enough information supporting its position that the use of IV tramadol outweighs the risks.
Advisory committee votes against IV tramadol
In the final phase of the meet, the advisory committee voted on the question, “Has the Applicant submitted adequate information to support the position that the benefits of their product outweigh the risks for the management of acute pain severe enough to require an opioid analgesic in an inpatient setting?” There were eight Yes votes and 14 No votes.
FDA Advisory Committees offer the FDA non-binding independent opinions and recommendations. The FDA previously indicated that the Office of New Drugs (OND) requires input from an Advisory Committee before deciding on Avenue’s formal dispute resolution request (“FDRR”) and that the OND will reply to Avenue’s FDRR within 30 days of the Advisory Committee meeting.
Oral tramadol used is approved in the US.
Tramadol is an opioid used in relieving pain but is currently approved for oral administration in the US. Once approved, Avenue’s IV tramadol will be the first injectable kind of tramadol hydrochloride available to patients in the US.
The agency indicated in briefing documents that the indication proposed by Avenue for approval is much wider compared to the standard use of immediate-release opioid analgesics. It added that opioid analgesics are often used in treating opioid-level pain, and they are only used when all other therapeutic choices have failed or have been ruled out.
Notably, the differences are essential considering safety risks of respiratory depression, abuse, addiction, misuse and death related to opioid use. Furthermore, the FDA expressed concern about tramadol IV’s delayed start of pain alleviation, citing potential safety risks.
Findings from 2 placebo-controlled third Phase studies support the company’s marketing application for the therapy.
