FDA rejects IV tramadol as opioid alternative for second time
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Avenue Therapeutics announced the FDA has issued a second complete response letter regarding the new drug application for intravenous tramadol as an analgesic treatment for patients with acute pain.
The FDA issues a complete response letter to an applicant if the agency determines that it will not approve the application or abbreviated application in its present form for one or more reasons. In this case, the FDA expressed concerns that the delayed and unpredictable onset of analgesia from IV tramadol made it unsuitable as a monotherapy to treat acute pain in patients.
Additionally, the FDA stated that there is insufficient information to support the safe and effective use of IV tramadol in combination with other analgesics for its intended patient population.
The agency had previously voiced these concerns in its first complete response letter in October 2020, noting that “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 likely choice would be another opioid, which would result in opioid ‘stacking’ and increase the likelihood of opioid-related adverse effects.”
In response to the first letter, Lucy Lu, MD, president and CEO of Avenue Therapeutics, expressed continued confidence in the use of tramadol for this patient population. “We believe that our extensive clinical database strongly supports the value of treatment with IV tramadol as an effective alternative to intravenous Schedule II conventional opioids,” she said. “We firmly stand behind the safety data in our NDA and the ultimate approvability of IV tramadol.”
Given the FDA’s latest rejection, Avenue Therapeutics stated in a press release that the company disagrees with the agency’s interpretation of the data in the NDA and intends to continue to pursue regulatory approval for IV tramadol.
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