Avenue Therapeutics Receives Interim Response to its Formal Dispute Resolution Request from U.S. Food and Drug Administration Office of New Drugs
Avenue Therapeutics (NASDAQ: ATXI) announced on October 25, 2021, that the FDA's Office of New Drugs requires additional input before deciding on the Formal Dispute Resolution Request regarding its intravenous tramadol. The FDA plans to hold an Advisory Committee meeting to gather advice from both the Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management Committees. A response to the FDRR is anticipated within 30 days after the meeting.
- None.
- Requirement for additional input from an Advisory Committee may delay regulatory approval.
- Uncertainty surrounding the timing of the FDA response could impact investor confidence.
Office of New Drugs concludes that additional input is needed, and U.S. Food and Drug Administration will convene an Advisory Committee meeting
NEW YORK, Oct. 25, 2021 (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 received a written interim response from the Office of New Drugs (“OND”) of the U.S. Food and Drug Administration (“FDA”). The letter indicated that the OND needs additional input from an Advisory Committee in order to reach a decision on the Formal Dispute Resolution Request (“FDRR”), the details of which have previously been disclosed.
Accordingly, the FDA will convene an Advisory Committee meeting and seek advice from the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The letter stated that the OND will respond to the FDRR within 30 calendar days after the Advisory Committee meeting.
About Avenue Therapeutics
Avenue Therapeutics is a specialty pharmaceutical company whose mission is to develop IV tramadol, a potential alternative that could reduce the use of conventional opioids, for patients suffering from acute pain in the U.S. Avenue is headquartered in New York City and was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit www.avenuetx.com.
About Fortress Biotech
Fortress Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical company that was ranked in Deloitte’s 2019 and 2020 Technology Fast 500™, annual rankings of the fastest-growing North American companies in the technology, media, telecommunications, life sciences and energy tech sectors, based on percentages of fiscal year revenue growth over three-year periods. Fortress is focused on acquiring, developing and commercializing high-potential marketed and development-stage drugs and drug candidates. The company has seven marketed prescription pharmaceutical products and over 25 programs in development at Fortress, at its majority-owned and majority-controlled partners and at partners it founded and in which it holds significant minority ownership positions. Such product candidates span six large-market areas, including oncology, rare diseases and gene therapy, which allow it to create value for shareholders. Fortress advances its diversified pipeline through a streamlined operating structure that fosters efficient drug development. The Fortress model is driven by a world-class business development team that is focused on leveraging its significant biopharmaceutical industry expertise to further expand the company’s portfolio of product opportunities. Fortress has established partnerships with some of the world’s leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including Alexion Pharmaceuticals, Inc., AstraZeneca, City of Hope, Fred Hutchinson Cancer Research Center, St. Jude Children’s Research Hospital, Nationwide Children’s Hospital and Sentynl Therapeutics, Inc. For more information, visit www.fortressbiotech.com.
Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to us obtaining regulatory approval from the FDA for our product candidate, risks relating to the COVID-19 outbreak and its potential impact on our employees’ and consultants’ ability to complete work in a timely manner, risks relating to our growth strategy; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
Contacts:
Jaclyn Jaffe and Bill Begien
Avenue Therapeutics, Inc.
(781) 652-4500
ir@avenuetx.com
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