Avenue Therapeutics Announces Positive Topline Data from Second Pivotal Phase 3 Study of Intravenous Tramadol in the Manageme...
June 03 2019 - 7:00AM
Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a specialty
pharmaceutical company focused on the development and
commercialization of intravenous (IV) tramadol, today announced
that its second pivotal Phase 3 trial of IV tramadol achieved the
primary endpoint of a statistically significant improvement in Sum
of Pain Intensity Difference over 24 hours (SPID24) compared to
placebo in patients with postoperative pain following
abdominoplasty surgery. In addition, the trial met all of its key
secondary endpoints. The study also includes a standard-of-care IV
opioid as an active comparator: IV morphine 4 mg. In this
study, IV tramadol also demonstrated similar efficacy and safety to
that of IV morphine.
“The strong safety and efficacy results from
this second Phase 3 trial are consistent with those from the first
Phase 3 trial in bunionectomy surgery and demonstrated the utility
of IV tramadol in post-surgical pain management regardless of the
surgery type,” said Lucy Lu, M.D., Avenue’s President and Chief
Executive Officer. “This study is a significant milestone for
Avenue because it brings us one step closer to submitting a New
Drug Application (NDA) to the U.S. Food and Drug Administration
(FDA), currently planned for year-end 2019.”
“IV tramadol may fill a gap between non-opioid
medicine and Schedule II opioids in the post-surgical setting and
has the potential to provide a convenient bridge to the widely
prescribed oral tramadol, a Schedule IV opioid,” said Neil Singla,
M.D., Chief Scientific Officer of Lotus Clinical Research and a
thought leader of acute pain trials. “The results from the study
demonstrated that IV tramadol is similarly potent to a conventional
opioid in patients with post-surgical pain, and therefore, it could
be a very important addition to the post-surgical pain
armamentarium.”
“We are pleased with these results,” said Dr.
Jaideep Gogtay, Chief Medical Officer at Cipla Limited and a board
member of Avenue. “We look forward to working with Avenue in
bringing a new and useful therapeutic option to U.S. patients
suffering from acute pain.”
Phase 3 Trial Design and
Results
The Phase 3 multicenter, randomized,
double-blind, placebo-controlled trial evaluated the efficacy and
safety of IV tramadol in 370 patients following abdominoplasty
surgery. Patients were randomized in a 3:3:2 ratio to a
postoperative regimen of 50 mg of IV tramadol, placebo, or 4 mg of
IV morphine at hours 0, 2, 4 and once every 4 hours thereafter,
respectively, for up to 13 doses over the course of 48 hours.
Morphine, a standard-of-care analgesic, was included to
obtain comparative safety data versus IV Tramadol.
The primary efficacy endpoint of the study
assessed the analgesic efficacy of IV tramadol compared to placebo
as measured by SPID24. The key secondary efficacy endpoints
included Patient Global Assessment at 24 hours (PGA 24), SPID48,
and total consumption of rescue medicine through 24 hours. A
key safety objective of the study was to compare the safety and
tolerability of IV tramadol to IV morphine.
IV tramadol 50 mg achieved the primary endpoint
of statistically superior improvement in pain relief as measured by
the SPID24 (p<0.001) compared to placebo, as well as met all
three key secondary endpoints (each statistically significant at p
< 0.001). IV tramadol and IV morphine demonstrated similar
efficacy benefits in the study.
IV tramadol was well-tolerated with no
drug-related serious adverse events in the trial. Most adverse
events were mild or moderate (Grade 1 or 2) with only 2 patients
experiencing a Grade 3 event (1 in the IV tramadol arm and 1 in the
IV morphine arm). The most common adverse events (>10%)
were:
|
Nausea (%) |
Vomiting (%) |
Headache (%) |
Dizziness (%) |
|
As reported |
Placebo-adjusted |
As reported |
Placebo-adjusted |
As reported |
Placebo-adjusted |
As reported |
Placebo-adjusted |
Placebo |
37.0 |
|
6.7 |
|
14.8 |
|
6.7 |
|
IV tramadol |
69.7 |
32.7 |
38.7 |
32.0 |
18.3 |
3.5 |
12.7 |
6.0 |
IV morphine |
78.5 |
41.5 |
45.2 |
38.5 |
23.7 |
8.9 |
18.3 |
11.6 |
Study completion rates were high for all
treatment groups (tramadol 87.9%, morphine 91.4%, placebo
93.4%).
Conference Call and Webcast
Avenue will host a conference call and webcast at 9:00 a.m. EDT
today to discuss the topline Phase 3 data. To participate in the
conference call, please dial (877) 273-6095 (domestic) or (647)
689-5538 (international) and enter the conference code: 6399686. A
live audio webcast will be available on the Events page of the
Investors section of Avenue’s website at www.avenuetx.com. A replay
of the audio webcast will be available approximately one hour after
the call on the Events page of the Investors section of Avenue’s
website for a period of 30 days following the call.
About IV TramadolTramadol is a synthetic,
dual-acting opioid with a unique mechanism of action that delivers
opioid efficacy with less potential for abuse and a lower risk of
dependence than conventional narcotics. Oral tramadol has a
well-established efficacy and safety profile, and is currently
approved and marketed in the U.S. for moderate to moderately severe
pain in adults. There is currently no approved IV formulation in
the U.S.
About Avenue TherapeuticsAvenue is a specialty
pharmaceutical company focused on the development and
commercialization of IV tramadol for the management of moderate to
moderately severe post-operative pain. Avenue is headquartered in
New York City and was founded by Fortress Biotech, Inc. (NASDAQ:
FBIO). In November 2018, Avenue announced definitive agreements
regarding an equity investment and contingent acquisition of Avenue
by InvaGen, a subsidiary of Cipla Limited, a leading pharmaceutical
company. The first stage of the transaction closed in February
2019. 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 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 Begien,
Investor RelationsAvenue Therapeutics, Inc.(781)
652‐4500 ir@avenuetx.com
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