Avenue Therapeutics Announces Publications in Peer-Reviewed Journals
June 05 2020 - 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 the following publications in
peer-reviewed journals.
The publication titled “Intravenous Tramadol is
Effective in the Management of Postoperative Pain Following
Abdominoplasty: A Three-Arm Randomized Placebo- and
Active-Controlled Trial” has been published in Drugs in R&D and
can be accessed here.
The objective of this Phase 3 study was to
evaluate the safety, tolerability and efficacy of IV tramadol 50 mg
versus placebo in patients following abdominoplasty surgery, a
soft-tissue surgical model. The study included an active comparator
arm, IV morphine 4mg. While the study was not powered to provide
statistical comparison of the two active arms, its sample size
allowed for assessment of the general comparability of the
treatment regimens. The results of the study demonstrated that IV
tramadol was statistically superior to placebo and comparable to IV
morphine for the primary and all key secondary efficacy outcomes.
IV tramadol also demonstrated numerically lower rates of incidence
of the most common treatment-emergent adverse events than IV
morphine.
The publication titled “IV Tramadol – A New
Treatment Option for Management of Post-Operative Pain in the U.S.:
An Open-Label, Single-Arm, Safety Trial Including Various Types of
Surgery” has been published in Journal of Pain Research and can be
accessed here.
This safety study was a Phase 3, single-arm,
open-label safety study performed in patients undergoing a variety
of elective bone and soft tissue surgeries to evaluate the safety
and tolerability of IV tramadol 50 mg. The study enrolled 251
patients with both orthopedic and soft tissue surgeries well
represented. Dosing was completed in 95% of the patients. IV
tramadol was well tolerated, and the adverse events were consistent
with known tramadol pharmacology. At the end of treatment,
approximately 95% of the patients reported that study medication
was good, very good, or excellent for controlling pain.
The publication titled “Misuse of Tramadol in
the United States: An Analysis of the National Survey of Drug Use
and Health 2002-2017” has been published in Substance Abuse:
Research and Treatment and can be accessed here.
The objective of the study was to analyze the
rates of misuse – use in any way not directed by a doctor – of
products containing oral tramadol, a Schedule IV opioid, as
compared to comparator Schedule II opioids (morphine, oxycodone,
and hydrocodone) and alprazolam, a commonly prescribed Schedule IV
controlled substance in the U.S. from the National Survey of Drug
Use and Health (“NSDUH”). NSDUH is an annual, congressionally
mandated household survey of self-reported alcohol, drug and
tobacco use among non-institutionalized persons (≥12 years old) in
the U.S. The study showed a low prevalence of oral tramadol misuse
as compared to other commonly prescribed opioids when adjusted for
prescription volume. Estimates of reported oral tramadol misuse
remained relatively stable over time. Reports of oral tramadol
misuse were also much less than alprazolam, another Schedule IV
drug.
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 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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