Avenue Therapeutics gets complete response letter from USFDA for intravenous tramadol

Drug firm Cipla on Monday said the company's step-down associate firm Avenue Therapeutics Inc has received a complete response letter (CRL) from the US health regulator for its new drug application for intravenous tramadol.

Drug firm Cipla on Monday said the company's step-down associate firm Avenue Therapeutics Inc has received a complete response letter (CRL) from the US health regulator for its new drug application for intravenous tramadol. The CRL from the US Food and Drug Administration (USFDA) has stated that the regulator has determined that it cannot approve the application for IV tramadol in its present form, Avenue Therapeutics said in a statement.

The letter stated that IV tramadol intended to treat patients in acute pain who require an opioid is not safe for the intended patient population, it added. "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. We firmly stand behind the safety 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 these issues in order to bring this important medicine to patients and clinicians in the US. Shares of Cipla Ltd on Monday closed at Rs 814.70 per scrip on the BSE, up 1.42 per cent from its previous close.