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Therapeutics Inc has received a complete response letter (CRL) in the US health regulator for its new drug application for intravenous tramadol.
The CRL in the US Food and Drug Administration (USFDA) has said that the regulator has decided it cannot approve the application for IV tramadol in its current form, Avenue Therapeutics said in a statement.
The letter said that IV tramadol intended to take care of patients in acute pain who need an opioid isn’t safe for its intended patient population, it added.
“We feel that our extensive clinical database strongly affirms the value of therapy with IV tramadol as an effective alternative to intravenous Schedule II traditional opioids. We firmly stand behind the security data in our NDA and the ultimate approvability of IV tramadol,” Avenue Therapeutics MD, President and CEO Lucy Lu said.
She added that we will request a meeting with the FDA as soon as possible and are committed to working closely with the agency to resolve those problems in order to bring this important medication to patients and clinicians in the US.
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