Avenue Therapeutics Announces Presentation of IV Tramadol E-Posters
April 23 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 that two e-posters highlighting
efficacy and safety results from its Phase 3 program are available
for online viewing from the cancelled Annual Regional
Anesthesiology and Acute Pain Medicine Meeting hosted by the
American Society of Regional Anesthesia and Pain Medicine (“ASRA”).
The meeting was originally scheduled to take place April 23-25,
2020 in San Francisco, CA and was cancelled due to COVID-19
concerns.
The e-poster (816) titled “Intravenous Tramadol
is Effective in Management of Postoperative Pain Following
Abdominoplasty: A 3-arm Randomized Controlled Trial” presents data
from the Phase 3 abdominoplasty study and can be found here.
This Phase 3, multicenter, double-blind, placebo
and active controlled trial evaluated the efficacy and safety of IV
tramadol in 370 patients following abdominoplasty surgery. Patients
were randomized to a postoperative regimen of IV tramadol 50 mg,
placebo or IV morphine 4 mg. The primary endpoint of the study
assessed the analgesic efficacy of IV tramadol compared to placebo
as measured by SPID24 (sum of pain intensity differences through 24
hours post first dose). The key secondary endpoints included SPID48
(sum of pain intensity differences through 48 hours post first
dose), total consumption of rescue medicine and Patient Global
Assessment. IV tramadol 50 mg was statistically significantly
superior to placebo for the primary efficacy endpoint and all three
key secondary efficacy endpoints. In addition, IV tramadol
demonstrated a similar efficacy profile to that of IV morphine 4
mg, a standard-of-care active comparator in this study. Topline
results from this study were announced in June 2019.
The e-poster (1001) titled “IV tramadol – A New
Treatment Option for Management of Post-Operative Pain: A Safety
Trial Including Various Types of Surgery”, presents data from the
Phase 3 safety study and can be found here.
The Phase 3 safety study was a single-arm open
label study that enrolled patients undergoing a range of surgical
procedures including both orthopedic and soft tissue surgeries. IV
tramadol 50 mg was administered at Hours 0, 2, 4, and every 4
hours thereafter for up to 7 days of treatment. Patients were
allowed to use non-opioid medications per treating physicians’
discretion if additional pain relief was needed. While efficacy was
not a primary objective of the study, patient satisfaction with
treatment was measured with Patient Global Assessment.
IV tramadol 50 mg was well tolerated in this
real-world trial, with only 4% of patients discontinuing for
adverse events. The most commonly observed adverse events were
nausea and vomiting, which is consistent with known tramadol
pharmacology. At the end of treatment, 95% of patients reported
that study medication was good, very good, or excellent for
controlling pain. No patients discontinued the study due to a lack
of efficacy.
“The results of these two studies indicate that
IV tramadol may become a useful option in patients where exposure
to conventional opioids is not desired,” said Harold Minkowitz,
M.D., an anesthesiologist at Memorial Hermann Memorial City Medical
Center in Houston, TX. “IV tramadol, with its dual mechanisms of
action, may fill a gap between IV non-opioid medicine and
conventional opioids. The availability of IV tramadol as an
alternative to conventional opioid analgesics should be a valuable
option for U.S. clinicians who treat pain in the hospital
setting.”
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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