Avenue Therapeutics Announces Submission of New Drug Application for IV Tramadol
Avenue Therapeutics, Inc. (ATXI)
Last avenue therapeutics, inc. earnings: 8/14 07:30 am
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Source: GlobeNewswire
NEW YORK, Dec. 11, 2019 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), 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
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ATXI
Sec Filings
- 4/17/24 - Form 4
- 4/17/24 - Form SC
- 3/29/24 - Form 8-K
- ATXI's page on the SEC website