Avenue Therapeutics submits NDA for IV tramadol

Avenue Therapeutics announced submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (USFDA) for IV tramadol, which is indicated for the management of moderate to moderately severe pain in adults in a medically supervised health care setting.

The NDA is based on positive results from two pivotal Phase 3 clinical efficacy and safety trials in patients following bunionectomy and abdominoplasty surgeries. It also includes an epidemiology study on abuse of tramadol in the U.S. and in certain European countries, where IV tramadol is available. Subsequently, the results show that tramadol abuse are infrequent and are in absolute number and relative to other prescription opioids. In countries, where it is available, the abuse of tramadol via injection is uncommon compared to oral tramadol.

Avenue Therapeutics is a New York-based, specialty pharmaceutical company, focused on the development of an Intravenous (IV) formulation of tramadol HCl (IV tramadol) for the management of moderate to moderately severe postoperative pain. The company entered into a two-stage acquisition agreement with InvaGen, which is a subsidiary of Cipla Limited. The first stage closing took place in February 2019 when InvaGen acquired a 33.3 per cent stake in Avenue Therapeutics on a fully diluted basis.

On Thursday, the stock of the company was trading at Rs. 458.40, up by 1.93 per cent or Rs. 8.70 per share. The 52-week high is Rs. 585.50 and 52-week low is Rs. 389.55 on BSE.