Avenue Therapeutics Announces that the FDA is Still Reviewing Its NDA Resubmission for IV Tramadol
Avenue Therapeutics announced that the FDA has not yet provided a decision on the New Drug Application (NDA) for IV tramadol. An acknowledgment letter from the FDA confirmed the resubmission was complete, with a PDUFA goal date set for April 12, 2021. The NDA resubmission followed a Complete Response Letter issued in October 2020, and included revised product labeling and sterilization reports. The company aims to develop IV tramadol as a potentially reduced risk alternative to traditional opioids for acute pain management.
- None.
- No decision from the FDA regarding NDA could delay potential revenue.
- Uncertainty surrounding regulatory approval presents ongoing risk to investors.
The FDA Has Not Provided a Decision Regarding the NDA
NEW YORK, April 13, 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 the U.S. Food and Drug Administration (“FDA”) was still reviewing its New Drug Application (“NDA”) for IV tramadol and had not provided a decision regarding the NDA.
An acknowledgement letter from the FDA in February 2021 stated that the Company’s resubmission of its NDA for IV tramadol was a complete, class 1 response to the Complete Response Letter (“CRL”) dated October 9, 2020 and the resubmission had been assigned a Prescription Drug User Fee Act (“PDUFA”) goal date of April 12, 2021.
The NDA for IV tramadol was resubmitted following the receipt of official minutes from a Type A meeting with the FDA, which was conducted following a CRL issued by the FDA in October 2020. The resubmission package included revised language relating to the proposed product label and a report relating to terminal sterilization validation.
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 and Nationwide Children’s Hospital. 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; risk that our contingent acquisition by InvaGen Pharmaceuticals is not consummated, or that a dispute involving such transaction arises; 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; 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
FAQ
What is the status of Avenue Therapeutics' NDA for IV tramadol as of April 2021?
What was the PDUFA goal date for Avenue Therapeutics' NDA submission?
What led to the resubmission of the NDA for IV tramadol by Avenue Therapeutics?
What is the purpose of developing IV tramadol by Avenue Therapeutics?
What does the Complete Response Letter from the FDA imply for Avenue Therapeutics?
