Avenue Therapeutics Announces Dosing of First Patient in Phase 3 Safety Trial of Intravenous Tramadol for the Management of P...
January 02 2018 - 8:00AM
Avenue Therapeutics, Inc. (NASDAQ:ATXI) (“Avenue”), a company
focused on the development and commercialization of intravenous
(IV) tramadol, today announced that it has dosed the first patient
in its Phase 3 safety trial of IV tramadol for the management of
moderate to moderately severe pain.
“We are pleased to announce the dosing of the
first patient in our Phase 3 safety trial of IV tramadol. This
safety study is a key component of our pivotal Phase 3 development
program and will be used to support our planned new drug
application (NDA), which we hope to submit to the U.S. Food and
Drug Administration in late 2019,” said Lucy Lu, M.D., Avenue’s
President and Chief Executive Officer. “We believe that IV
tramadol, which has been used widely outside the U.S., has the
potential to fill the gap between IV acetaminophen/NSAIDs and
conventional IV narcotics, and may help circumvent the use of
conventional narcotics. We look forward to rapidly advancing our
pivotal program, which will bring us closer to our goal of making
available the first Schedule IV intravenous opioid in the U.S.”
The Phase 3, multicenter, open-label trial will
evaluate the safety of IV tramadol 50 mg in the management of
postoperative pain following surgery. The trial will enroll
approximately 250 patients to receive 50 mg of IV tramadol over 15
minutes at zero, two and four hours, then once every four hours
thereafter.
Avenue Therapeutics is currently evaluating IV
tramadol in a Phase 3 trial in patients following
bunionectomy surgery, and expects to report topline data in
the second quarter of 2018. The Company expects to initiate a
second Phase 3 trial in patients following abdominoplasty surgery
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 BiotechFortress
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: Jaclyn JaffeAvenue Therapeutics, Inc.
(781) 652-4500ir@avenuetx.com
Investor RelationsJulie SeidelStern Investor Relations,
Inc.(212) 362-1200julie@sternir.com
Media RelationsSarah HallPhase IV Communications(215)
313-5638sarah@phaseivcommunications.com
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