Shares of micro-cap biopharma Avenue Therapeutics Inc (NASDAQ:ATXI) are plummeting on above-average volume after a binary event panned out against the company.
What Happened: New York-based Avenue said the FDA has issued a complete response letter regarding its NDA for intravenous tramadol.
The PDUFA date was scheduled for Oct. 10.
While taking cognizance of the investigational drug meeting all primary and many secondary endpoints in pivotal late-stage studies, FDA said the NDA cannot approve the application in the present form.
"The CRL stated that IV tramadol, intended to treat patients in acute pain who require an opioid, is not safe for the intended patient population," the company said in a press release.
For patients requiring an analgesic between the first dose of intravenous tramadol and the onset of analgesia, the likely rescue analgesic option would be another opioid, leading to opioid stacking and increasing the likelihood of opioid-related adverse effects, the CRL said.
The regulatory agency, however, did not identify any safety signals with respect to the company's clinical development program.
Why It's Important: Intravenous tramadol is a centrally-acting atypical opioid with a dual mechanism of action that is designated Schedule IV. It carries less abuse liability than conventional opioid analgesic medications, all of which are designated Schedule II.
"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," said Lucy Lu, CEO of Avenue.
What's Next: Avenue said it plans to conduct an adequate terminal sterilization validation, given FDA's mandate for it prior to NDA approval.
The company also said it will request a meeting with the FDA as soon as possible and is committed to working closely with the agency to resolve these issues.
Avenue shares were slumping 57% to $4.67 at publication time.