Avenue Therapeutics Receives Complete Response Letter from the FDA for IV Tramadol
October 12 2020 - 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 it has received a Complete Response
Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”)
regarding the Company’s New Drug Application (“NDA”) for IV
tramadol.
The CRL stated that although the pivotal Phase 3
clinical trials demonstrated statistically significant outcomes for
all of the primary and many secondary endpoints, the FDA has
determined that it cannot approve the application in its present
form. The CRL stated that IV tramadol, intended to treat patients
in acute pain who require an opioid, is not safe for the intended
patient population. Specifically, if a patient requires an
analgesic between the first dose of IV tramadol and the onset of
analgesia, a rescue analgesic would be needed. The likely choice
would be another opioid, which would result in opioid “stacking”
and increase the likelihood of opioid-related adverse effects.
Other than this potential safety concern, the FDA did not identify
a safety signal in Avenue’s clinical development program. In
addition, the CRL stated that the FDA requires an adequate terminal
sterilization validation prior to NDA approval, which is planned
for later this quarter.
“We believe that our extensive clinical database
strongly supports the value of treatment with IV tramadol as an
effective alternative to intravenous Schedule II conventional
opioids. We firmly stand behind the safety data in our NDA and the
ultimate approvability of IV tramadol,” said Lucy Lu, MD, President
and Chief Executive Officer of Avenue Therapeutics. “We will
request a meeting with the FDA as soon as possible and are
committed to working closely with the agency to resolve these
issues in order to bring this important medicine to patients and
clinicians in the U.S.”
Conference
CallAvenue management will be
hosting a conference call today beginning at 8:30 a.m. ET. To
access the conference call, please dial (833) 900-1539 (local) or
(236) 712-2279 (international) a few minutes prior to the start
time and refer to conference ID 9467696. An archived audio will be
available in the Investors section under Events on the Company's
website a few hours after the event and will be available for 30
days.
About Avenue
Therapeutics Avenue 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 recently ranked number 10 in Deloitte’s 2019
Technology Fast 500™, an annual ranking of the fastest-growing
North American companies in the technology, media,
telecommunications, life sciences and energy tech sectors, based on
percentage of fiscal year revenue growth over a three-year period.
Fortress is focused on acquiring, developing and commercializing
high-potential marketed pharmaceutical products and
development-stage pharmaceutical 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.
Contacts: Jaclyn Jaffe and William BegienAvenue
Therapeutics, Inc. (781) 652-4500ir@avenuetx.com
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