Avenue Therapeutics Announces Dosing of First Patient in Second Pivotal Phase 3 Clinical Trial of Intravenous Tramadol for th...
19 Dezembro 2018 - 11:00AM
Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a specialty
pharmaceutical company focused on the development and
commercialization of intravenous (IV) tramadol, today announced
that the first patient has been dosed in a pivotal Phase 3 clinical
trial of IV tramadol for the management of moderate to moderately
severe pain in patients following abdominoplasty surgery.
“The commencement of the Phase 3 abdominoplasty study is a key
step in the advancement of the clinical development for IV
tramadol. This study not only compares the efficacy and safety of
IV tramadol to placebo, but also compares the safety and
tolerability of IV tramadol to an active comparator (IV morphine),”
said Lucy Lu, M.D., Avenue’s President and Chief Executive Officer.
“This is an important aspect of the study, because IV tramadol, if
approved, will be used in the hospital setting where IV opioids are
already being used and it may be a better alternative for many
patients.”
The Phase 3, multicenter, randomized, double-blind, three-arm
trial will evaluate the efficacy and safety of IV tramadol 50 mg
versus placebo. Approximately 360 patients will be enrolled to IV
tramadol 50 mg, placebo or morphine in a 3:3:2 ratio. The primary
efficacy endpoint is the summed pain intensity difference over 24
hours (SPID24) compared to placebo. Additional information on the
study can be found on www.clinicaltrials.gov using the
identifier NCT03774836.
About Avenue TherapeuticsAvenue, a Fortress
Biotech 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”) (NASDAQ: FBIO) 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
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 licensing arrangements, 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 Jaffe and William Begien
Investor RelationsAvenue Therapeutics, Inc.(781) 652‐4500
ir@avenuetx.com
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