Avenue Therapeutics Announces New Drug Application for IV Tramadol Accepted for Review by FDA
February 13 2020 - 8:00AM
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”) has accepted for review Avenue’s New Drug
Application (“NDA”) for IV tramadol for the management of moderate
to moderately severe pain in adults in a medically supervised
health care setting. The FDA set a Prescription Drug User Fee Act
(“PDUFA”) goal action date of October 10, 2020.
“The NDA submission acceptance is another
important step toward bringing IV tramadol to patients and their
healthcare providers in the U.S.,” said Lucy Lu, M.D., Avenue’s
President and Chief Executive Officer. “We look forward to working
with the FDA as they evaluate our application.”
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.
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 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.
Contacts: Jaclyn Jaffe and William BegienAvenue
Therapeutics, Inc. (781) 652-4500ir@avenuetx.com
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