Avenue Therapeutics Announces Submission of New Drug Application for IV Tramadol
December 11 2019 - 8:30AM
Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a company
focused on the development of intravenous (“IV”) tramadol for the
U.S. market, today announced that it has submitted a New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA)
for IV tramadol for the management of moderate to moderately severe
pain in adults in a medically supervised health care setting.
The NDA for IV tramadol is based on positive
results from two pivotal Phase 3 clinical efficacy and safety
trials in patients following bunionectomy and abdominoplasty
surgeries, as well as an open-label safety study with a total of
more than 500 patients who received the IV tramadol 50 mg dosing
regimen. In addition, the NDA includes an epidemiology study
on abuse of tramadol in the U.S. and in certain European countries
where IV tramadol is available. The study finds that reports of
abuse with tramadol are infrequent, both in absolute number and
relative to other prescription opioids, and that abuse of tramadol
via injection is uncommon relative to oral tramadol in countries
where it is available.
“As a potential alternative that could reduce
the use of conventional opioids, IV tramadol may fill a gap between
IV acetaminophen/NSAIDs and IV conventional narcotics in the acute
pain space,” said Lucy Lu, M.D., Avenue’s President and Chief
Executive Officer. “The submission of this NDA is an important
milestone for our company, and we look forward to working closely
with the FDA during the review process.”
About Avenue TherapeuticsAvenue Therapeutics is
a specialty pharmaceutical company whose mission is to develop
intravenous (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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