Avenue Therapeutics Announces Outcome of FDA Advisory Committee Meeting on IV Tramadol
February 15 2022 - 10:00PM
Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a company
focused on the development of intravenous (“IV”) tramadol for the
U.S. market, today announced the outcome of the U.S. Food and Drug
Administration (“FDA”) joint meeting of the Anesthetic and
Analgesic Drug Products Advisory Committee and the Drug Safety and
Risk Management Advisory Committee on IV tramadol.
In the final part of the public meeting, the
Advisory Committee voted yes or no on the following question: “Has
the Applicant submitted adequate information to support the
position that the benefits of their product outweigh the risks for
the management of acute pain severe enough to require an opioid
analgesic in an inpatient setting?” The results are 8 yes votes and
14 no votes.
FDA Advisory Committees provide the FDA with
independent advice and non-binding recommendations. The FDA has
previously stated that input from an Advisory Committee is needed
for the Office of New Drugs (“OND”) to reach a decision on Avenue’s
formal dispute resolution request (“FDRR”) and that the OND will
respond to Avenue’s FDRR within 30 calendar days after the Advisory
Committee meeting.
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. For more
information, visit www.avenuetx.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 Bill BegienAvenue
Therapeutics, Inc. (781) 652-4500ir@avenuetx.com
Avenue Therapeutics (NASDAQ:ATXI)
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