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Avenue Therapeutics Announces New Drug Application For IV Tramadol

Avenue Therapeutics, Inc., A company focused on the development of intravenous (“IV”) tramadol for the U.S. market, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for IV tramadol for the management of moderate to moderately severe pain in adults in a medically supervised health care setting.

The NDA for IV tramadol is based on positive results from two pivotal Phase 3 clinical efficacy and safety trials in patients following bunionectomy and abdominoplasty surgeries, as well as an open-label safety study with a total of more than 500 patients who received the IV tramadol 50 mg dosing regimen. In addition, the NDA includes an epidemiology study on abuse of tramadol in the U.S. and in certain European countries where IV tramadol is available. The study finds that reports of abuse with tramadol are infrequent, both in absolute number and relative to other prescription opioids, and that abuse of tramadol via injection is uncommon relative to oral tramadol in countries where it is available.

“As a potential alternative that could reduce the use of conventional opioids, IV tramadol may fill a gap between IV acetaminophen/NSAIDs and IV conventional narcotics in the acute pain space,” said Lucy Lu, M.D., Avenue’s President and Chief Executive Officer. “The submission of this NDA is an important milestone for our company, and we look forward to working closely with the FDA during the review process.”

Shares of CIPLA LTD. was last trading in BSE at Rs.449.7 as compared to the previous close of Rs. 453. The total number of shares traded during the day was 47213 in over 1003 trades.

The stock hit an intraday high of Rs. 452.9 and intraday low of 446.85. The net turnover during the day was Rs. 21225301.-Equity Bulls

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