FDA sends small biotech and its reformulated pain med packing, triggering a collapse in the share price
A small-cap biotech founded by Fortress has run into a brick wall at the FDA.
Avenue Therapeutics $ATXI says the agency has hit it with a complete response letter for its pitch on IV tramadol to treat post-operative pain. According to the biotech, regulators said that the IV approach wasn’t safe, as any additional need for quick pain relief would likely lead to “opioid stacking.”
The drug hasn’t received much attention from analysts, but investors clearly thought that the reformulation was a shoo-in. Ahead of the bell this morning, its shares were routed, plunging 57%.
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 likely choice would be another opioid, which would result in opioid “stacking” and increase the likelihood of opioid-related adverse effects. Other than this potential safety concern, the FDA did not identify a safety signal in Avenue’s clinical development program. In addition, the CRL stated that the FDA requires an adequate terminal sterilization validation prior to NDA approval, which is planned for later this quarter.
Avenue CEO Lucy Lu noted in a prepared statement that Avenue is sticking with its program for reformulated Tramadol — an old generic first approved 25 years ago — and will look to secure a meeting ASAP with the FDA to see what it will take to get the application back on track.
Avenue’s regulatory strategy had rested significantly on the idea of offering patients a non-opioid option as they stepped through pain meds — fitting into the FDA’s encouragement of non-opioids in the midst of widespread abuse. And investigators highlighted evidence of its efficacy over a placebo while also posting comparative results to 4 mg of IV morphine.
Avenue is part of the Fortress stable of biotech startup companies.