IV tramadol achieved primary and key secondary
endpoints, as well as a clear dose response
Avenue Therapeutics, Inc. (NASDAQ:ATXI) (“Avenue”), a company
focused on the development and commercialization of intravenous
(IV) tramadol, today announced that its first pivotal Phase 3 trial
of IV tramadol achieved the primary endpoint of a statistically
significant improvement in Sum of Pain Intensity Difference over 48
hours (SPID48) compared to placebo in patients with moderate to
moderately severe postoperative pain following bunionectomy
surgery. In addition, the trial met its key secondary endpoints and
demonstrated a clear dose response. Avenue plans to initiate a
second pivotal Phase 3 trial of IV tramadol in patients following
abdominoplasty surgery in the third quarter of 2018.
“There is a clear need for new therapies in the
postoperative pain setting, where patients are often treated with
Schedule II narcotics due to a lack of other options,” said Harold
Minkowitz, M.D., an investigator in IV tramadol's Phase 3 program.
“IV tramadol, which acts by a dual mechanism, is widely used
outside the U.S. in the postoperative setting. These Phase 3
results demonstrate that IV tramadol is well tolerated and rapidly
and effectively induces pain relief in patients following
bunionectomy surgery, a generally painful procedure, and suggest
that IV tramadol could be an important new therapy for managing
postoperative pain in our patients.”
“We are greatly encouraged by the strong safety
and efficacy results from our first Phase 3 trial, which support IV
tramadol’s potential to provide an improved IV treatment option for
postsurgical pain, and to fill a significant gap between IV NSAIDs
and Schedule II opioids,” said Scott Reines, M.D., Ph.D., Avenue’s
Chief Medical Officer. “Moreover, the trial clearly defined the 50
mg dose that will be applied in our second Phase 3 trial in
patients following abdominoplasty surgery as well as in our ongoing
safety trial.”
“IV tramadol has the potential to provide a
convenient bridge to the widely prescribed oral tramadol. This
combination could displace Schedule II narcotics altogether for
many patients, and provide a treatment option with less potential
for abuse and a lower risk of dependence,” said Lucy Lu, M.D.,
Avenue’s President and Chief Executive Officer. “We are excited
about these results and look forward to initiating a second pivotal
Phase 3 trial in the third quarter and, assuming positive data from
that study and our ongoing safety trial, we anticipate filing an
NDA with the U.S. Food and Drug Administration in late 2019.”
Phase 3 Trial Design and
Results
The Phase 3, multicenter, double-blind,
placebo-controlled trial evaluated the efficacy and safety of IV
tramadol in 409 patients following bunionectomy surgery. Patients
were randomized in a 1:1:1 ratio to a postoperative regimen of 50
mg of IV tramadol, 25 mg of IV tramadol or placebo administered
over 15 minutes at hours 0, 2, 4 and once every 4 hours thereafter,
for up to 13 doses. Based on a previous pharmacokinetic study, the
50 mg dosing regimen produces a similar Cmax (peak serum
concentration) and AUC (area under the curve) to those of 100 mg
oral tramadol given every 6 hours at steady state and reaches such
Cmax after the third dose at hour 4.
The primary endpoint of the bunionectomy study
assessed the analgesic efficacy of IV tramadol compared to placebo
as measured by SPID48. The key secondary endpoints included SPID24,
total consumption of rescue medicine and Patient Global Assessment,
which captures patients’ perception of the treatment.
The IV tramadol 50 mg treatment arm achieved the
primary endpoint of statistically superior improvement in SPID48
(p=0.005) compared to placebo. The 50 mg arm also met all three key
secondary endpoints (p < 0.01). The profile of pain intensity
over time demonstrated that IV tramadol 50 mg achieved
statistically significant improvement in pain reduction as early as
½ hour (the first assessment timepoint) after dosing. The IV
tramadol 25 mg treatment arm generally displayed intermediate
results that fell between the 50 mg and the placebo arms, with a
dose response observed across each of the primary and key secondary
efficacy endpoints.
IV tramadol was well-tolerated with no reports
of drug-related serious adverse events in the trial. One patient in
the 50 mg IV tramadol arm discontinued the trial due to an adverse
event (vomiting). The most common (≥5%) adverse events in the trial
where IV tramadol 50 mg differed from placebo were nausea,
vomiting, dizziness and somnolence. However, most of these adverse
events were mild or moderate (Grade 1 or 2) with only 4 (3%)
patients experiencing a Grade 3 event (vomiting) and no Grade 4
events in the IV tramadol 50 mg group. The overall safety profile
of the IV tramadol 50 mg arm is consistent with known tramadol
pharmacology and in this trial appeared to have a better
tolerability profile than historical data of IV opioids in similar
settings, which will be explored in Avenue’s next Phase 3
trial.
Detailed trial results will be submitted for
presentation at a future scientific conference or for publication
in a journal.
Conference Call and Webcast
Avenue will host a conference call and webcast at 8:30 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: 2999651. 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.
Avenue is evaluating IV tramadol in a pivotal
Phase 3 clinical program: a trial in patients following
bunionectomy surgery (NCT03290378) has been completed and a safety
study (NCT03395808) is ongoing. A pivotal Phase 3 trial in patients
following abdominoplasty surgery is expected to initiate in the
third quarter of 2018.
About Avenue TherapeuticsAvenue
Therapeutics, Inc. (“Avenue”), a Fortress Biotech (NASDAQ:FBIO)
Company, is a specialty pharmaceutical company focused on the
development and commercialization of intravenous (IV) tramadol for
the management of moderate to moderately severe postoperative pain.
IV tramadol may fill a gap in the acute pain market between IV
acetaminophen/NSAIDs and IV conventional narcotics. Avenue is
currently evaluating IV tramadol in a pivotal Phase 3 program for
the management of postoperative pain. Avenue is headquartered in
New York City. For more information, visit
www.avenuetx.com.
About Fortress Biotech Fortress
Biotech, Inc. (“Fortress”) is a biopharmaceutical company dedicated
to acquiring, developing and commercializing novel pharmaceutical
and biotechnology products. Fortress develops and commercializes
products both within Fortress and through certain of its subsidiary
companies, also known as Fortress Companies. In addition to its
internal development programs, Fortress leverages its
biopharmaceutical business expertise and drug development
capabilities and provides funding and management services to help
the Fortress Companies achieve their goals. Fortress and the
Fortress Companies may seek licensings, acquisitions, partnerships,
joint ventures and/or public and private financings to accelerate
and provide additional funding to support their research and
development programs. 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 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:
Investor RelationsJulie SeidelStern Investor Relations,
Inc.212-362-1200julie@sternir.com
Jaclyn Jaffe Avenue Therapeutics, Inc. (781) 652-4500
ir@avenuetx.com
Media RelationsSarah HallPhase IV Communications(215)
313-5638sarah@phaseivcommunications.com
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