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According to the detailed information of the complete response letter (CRL) issued a few days ago, the US Food and Drug Administration (FDA) once again refused to approve Avenue Therapeutics intravenous injection, the non-opioid painkiller tramadol
.
In the new CRL, the FDA stated that when tramadol alone is administered to treat acute pain, the unpredictability and delayed analgesia of intravenous therapy are not enough to prove the benefits of the therapy
.
In addition, the FDA stated in the CRL that so far there is not enough data to support the safety and effectiveness of intravenous tramadol and other analgesics in the expected approved population
In a statement issued by Avenue Therapeutics, the company stated that it "does not agree with the FDA's interpretation of the data in the NDA and intends to continue to seek regulatory approval for the intravenous drug tramadol
.
" This is the second CRL sent by the FDA to Avenue to In response to the company's desire to approve intravenous tramadol
The company resubmitted the NDA in April this year
.
Initially, the FDA made a decision to refuse on the grounds that the agency had safety issues
The drug was submitted to the NDA in December 2019, and positive results from two phase III studies were also submitted
.
In addition to an open-label safety study of more than 500 patients receiving 50 mg treatment, these key trials also evaluated the efficacy of intravenous tramadol in patients after bunionectomy and abdominal plastic surgery
In addition, the initial NDA submission also included data from epidemiological studies on tramadol abuse in the United States and some European countries
.
In this study, the researchers found that reports of tramadol abuse were not common, either in absolute amounts or relative to other opioids
Real data published in the journal Drug and Alcohol Dependence last December compared the misuse and abuse of codeine, morphine, and oxycodone treatments
.
The lead research investigator and PhD of Science Janetta L.
Reference source: FDA Once Again Rejects Avenue Therapeutics' NDA for IV Non-Opioid Painkiller
