Avenue Therapeutics

3 Columbus Circle
15th Floor
New York
New York
10019
United States

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36 articles with Avenue Therapeutics

  • The FDA stated that the unpredictable and delayed analgesia onset with the intravenous therapy could not support a benefit when given alone to manage acute pain. 
  • Avenue Therapeutics, Inc., a company focused on the development of intravenous tramadol for the U.S. market, announced that it has received a second Complete Response Letter from the U.S. Food and Drug Administration regarding its New Drug Application seeking approval for IV tramadol.

  • Avenue Therapeutics, Inc., a company focused on the development of intravenous tramadol for the U.S. market, announced that the U.S. Food and Drug Administration was still reviewing its New Drug Application for IV tramadol and had not provided a decision regarding the NDA.

  • The U.S. Food and Drug Administration’s schedule for April has several PDUFA dates scattered across the rest of the month. Here’s a look.
  • Avenue Therapeutics, Inc. (NASDAQ: ATXI) (Avenue), a company focused on the development of intravenous (IV) tramadol for the U.S. market, today announced that a publication titled “Tramadol Non-Medical Use in Four European Countries: A Comparative Analysis” has been published in Drug and Alcohol Dependence, a peer-reviewed international journal devoted to research,

  • Avenue Therapeutics, Inc. (NASDAQ: ATXI) (Avenue), a company focused on the development of intravenous (IV) tramadol for the U.S. market, today announced that a publication titled “Real-World Data on Nonmedical Use of Tramadol from Patients Evaluated for Substance Abuse Treatment in the NAVIPPRO Addiction Severity Index‒Multimedia Version (ASI-MV®) Network” has been published in Drug Safety,

  • Avenue Therapeutics, Inc. (NASDAQ: ATXI) (Avenue), a company focused on the development of intravenous (IV) tramadol for the U.S. market, today provided a regulatory update following receipt of the official meeting minutes from a November 2020 Type A meeting with the U.S. Food and Drug Administration (FDA) relating to a path forward for IV tramadol. Avenue had requested this Type A meeting to address a Complete Response Letter (CRL) it received fro

  • Avenue Therapeutics, Inc., a company focused on the development of intravenous tramadol for the U.S. market, announced it has received a Complete Response Letter from the U.S. Food and Drug Administration regarding the Company’s New Drug Application for IV tramadol.

  • Although the Phase III trial for the intravenous formulation demonstrated statistically significant outcomes for all of the primary and many secondary endpoints, the FDA rejected the application.
  • Although October doesn’t appear to be a very busy month for the U.S. Food and Drug Administration’s PDUFA dates, there are a few. Here’s a look at the next two weeks.
  • Avenue Therapeutics, Inc., a company focused on the development of intravenous tramadol for the U.S. market, announced that a publication entitled “IV tramadol: A novel option for US patients with acute pain—A review of its pharmacokinetics, abuse potential and clinical safety record” has been published in the peer-reviewed journal, Journal of Opioid Management, and can be accessed here.

  • Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a company focused on the development of intravenous (“IV”) tramadol for the U.S. market, today reported financial results and recent corporate highlights for the second quarter ended June 30, 2020. “We were pleased to announce several publications pertaining to IV tramadol in peer-reviewed journals recently. These publications highlight the positive data and accomplishments from our Phase 3 progr

  • NEW YORK, July 21, 2020 (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 the results from its Phase 3 study of IV tramadol in patients undergoing bunionectomy have been published in the peer-reviewed journal, Pain and Therapy. The objective of this Phase 3 study was to compare the analgesic benefit and tolerability of two doses of IV tramadol (50 mg and 25 m

  • Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a company focused on the development of intravenous (“IV”) tramadol for the U.S. market, today announced the following publications in peer-reviewed journals. The publication titled “Intravenous Tramadol is Effective in the Management of Postoperative Pain Following Abdominoplasty: A Three-Arm Randomized Placebo- and Active-Controlled Trial” has been published in Drugs in R&D and can be acc

  • 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 will host the Company’s 2020 Annual Meeting of Stockholders (“Annual Meeting”) virtually due to public health concerns resulting from the coronavirus (COVID-19) outbreak, and government-recommended and required limits on public gatherings. Holding the Annual Meeting online will also prote

  • Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a company focused on the development of intravenous (“IV”) tramadol for the U.S. market, today reported financial results and recent corporate highlights for the first quarter ended March 31, 2020. “In the first quarter of 2020, the U.S. Food and Drug Administration (“FDA”) accepted our IV tramadol New Drug Application (“NDA”) submission for review and set a Prescription Drug User Fee Act (“PDUFA”

  • Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a company focused on the development of intravenous (“IV”) tramadol for the U.S. market, today announced that two e-posters highlighting efficacy and safety results from its Phase 3 program are available for online viewing from the cancelled Annual Regional Anesthesiology and Acute Pain Medicine Meeting hosted by the American Society of Regional Anesthesia and Pain Medicine (“ASRA”). The meeting w

  • Avenue Therapeutics, Inc., a company focused on the development of intravenous tramadol for the U.S. market, reported financial results and recent corporate highlights for the year ended December 31, 2019..

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

  • 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