Avenue Therapeutics Provides Regulatory Update for IV Tramadol
December 17 2020 - 7:00AM
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 from the FDA
regarding the New Drug Application (NDA) for IV tramadol. Avenue
intends to resubmit the NDA in February 2021, barring any Covid-19
related or other setbacks. The NDA resubmission will incorporate
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 BiotechFortress
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 pharmaceutical products and product candidates.
The company has five 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, InvaGen Pharmaceuticals Inc. (a subsidiary
of Cipla Limited), 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, 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 William BegienAvenue
Therapeutics, Inc. (781) 652-4500ir@avenuetx.com
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