Avenue Therapeutics Announces Publication of IV Tramadol Phase 1 Clinical Data in Clinical Pharmacology in Drug Development
October 28 2019 - 8:30AM
Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a company
focused on the development of intravenous (“IV”) tramadol for the
U.S. market, announced today that its Phase 1 data on intravenous
(IV) tramadol has been published in the peer-reviewed journal
Clinical Pharmacology in Drug Development. Based on the results of
the study, Avenue chose the IV tramadol 50 mg dosing regimen for
Phase 3 development.
The objective of this Phase 1, open-label,
single investigational center, three-treatment, three-period,
multidose crossover study was to compare the pharmacokinetics of
two novel IV tramadol dosing regimens to oral tramadol 100 mg given
every six hours, the highest approved oral dosage in the United
States. Compared to the oral regimen, IV tramadol 50 mg
administered at hours 0, 2, and 4 and every 4 hours thereafter
reached initial tramadol peak serum concentration (Cmax) more
rapidly, while resulting in similar overall steady-state Cmax and
area under the plasma concentration–time curve, and that the
primary metabolite, M1, had lower area under the plasma
concentration–time curve and Cmax than for the oral regimen. The IV
tramadol 50 mg dosing regimen was well tolerated, with adverse
event profiles consistent with the known pharmacological effects of
tramadol.
The paper titled “Comparing the Pharmacokinetics of 2 Novel
Intravenous Tramadol Dosing Regimens to Oral Tramadol: A Randomized
3-Arm Crossover Study”, can be accessed here.
About Avenue TherapeuticsAvenue 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 has
completed its Phase 3 program of IV tramadol for the management of
postoperative pain and plans to submit a New Drug Application to
the U.S. Food and Drug Administration by year-end. 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 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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