Avenue Therapeutics Announces that the FDA is Still Reviewing Its NDA Resubmission for IV Tramadol
April 13 2021 - 6:30AM
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 TherapeuticsAvenue
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 StatementsThis
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 BegienAvenue
Therapeutics, Inc.(781) 652-4500ir@avenuetx.com
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