Avenue Therapeutics Announces Publication of Phase 3 Bunionectomy Study Results
July 21 2020 - 08:30AM
Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a company
focused on the development of intravenous (“IV”) tramadol for the
U.S. market, today announced that the results from its Phase 3
study of IV tramadol in patients undergoing bunionectomy have been
published in the peer-reviewed journal, Pain and Therapy.
The objective of this Phase 3 study was to
compare the analgesic benefit and tolerability of two doses of IV
tramadol (50 mg and 25 mg) to placebo in adult patients undergoing
bunionectomy, an orthopedic surgical model. Eligible patients were
randomized (1:1:1 ratio) to IV tramadol 50 mg, 25 mg or
placebo. The primary endpoint was the summary of pain
intensity differences (“SPID”) over 48 hours. Key secondary
endpoints included SPID over 24 hours, total consumption of rescue
analgesia, and patient global assessment of efficacy. Safety
assessments included treatment emergent adverse events (“TEAEs”),
clinical laboratory tests, vital signs, and electrocardiograms
(“ECG”). Assessment of the dose-response was an important
objective of the study. The study established a clear dose
response, with IV tramadol 50 mg demonstrating a statistically
significant benefit (p < 0.05) over placebo for primary and all
key secondary efficacy endpoints, whereas IV tramadol 25 mg
demonstrated intermediate results between the 50 mg and placebo
arms. IV tramadol 50 mg was well-tolerated. The most common
TEAEs were nausea and vomiting, and there were no meaningful
differences among the treatments for vital signs, ECG, and
laboratory assessments. The largest proportion of patients
completed IV tramadol 50 mg (98.6%) compared to IV tramadol 25 mg
(91.8%) and placebo (88.2%). The study concluded that IV tramadol
50 mg was effective and well-tolerated as a treatment for
postoperative pain following bunionectomy surgery, while IV
tramadol 25 mg, although well-tolerated, was judged to be an
ineffective dose for the treatment of pain in this setting.
Based on the results of the study, IV tramadol
50 mg was further developed in Avenue’s Phase 3 program. The
publication titled “Efficacy and Safety of Intravenously
Administered Tramadol in Patients with Moderate to Severe Pain
Following Bunionectomy: A Randomized, Double-Blind,
Placebo-Controlled, Dose-Finding Study” can be accessed here.
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
Fortress Biotech (NASDAQ:FBIO)
Historical Stock Chart
From Feb 2024 to Mar 2024
Fortress Biotech (NASDAQ:FBIO)
Historical Stock Chart
From Mar 2023 to Mar 2024