Trevena to Present Oliceridine, a Next Generation IV Opioid for the Management of Moderate to Severe Acute Pain, at FDA Advis...
September 10 2018 - 04:01PM
Trevena, Inc. (NASDAQ: TRVN), today announced that the U.S. Food
and Drug Administration (FDA) has scheduled a meeting of the
Anesthetic and Analgesic Drug Products Advisory Committee on
October 11, 2018 in Silver Spring, MD, to discuss the safety and
efficacy of oliceridine injection for the management of moderate to
severe acute pain.
The Company‘s New Drug Application (NDA) submission for
oliceridine was accepted for review by the FDA on January 2, 2018.
The Prescription Drug User Fee Act (PDUFA) target date for
completion of review by FDA of November 2, 2018 remains
unchanged.
“We look forward to the Advisory Committee meeting on October 11
and the opportunity to present our perspectives on the oliceridine
clinical data and its potential role in treating moderate to severe
acute pain,” said Maxine Gowen, President and Chief Executive
Officer. “We remain committed to working closely with the FDA
towards achieving the goal of ensuring hospital patients who
require an IV opioid to manage their moderate to severe acute pain
have access to effective and safe treatment options.”
Members of the Anesthetic and Analgesic Drug Products Advisory
Committee will review and evaluate available data regarding safety
and effectiveness and make appropriate recommendations. All final
decisions will be made by the FDA.
About Oliceridine Injection
Oliceridine injection is an investigational next generation IV
analgesic for the management of moderate to severe acute pain in
the hospital and similar settings and has been granted Breakthrough
Therapy designation by the U.S. Food and Drug Administration (FDA).
Oliceridine injection was specifically designed to improve
conventional opioid pharmacology to deliver the pain-reducing
potential of an opioid but with fewer opioid-related adverse
effects. Oliceridine is an investigational product and has not been
approved by the FDA or any other regulatory agency. If approved,
the Company expects oliceridine to be a Schedule II controlled
substance.
About Trevena
Trevena, Inc. is a biopharmaceutical company developing
innovative therapies based on breakthrough science to benefit
patients and healthcare providers confronting serious medical
conditions. The Company has discovered four novel and
differentiated drug candidates, including oliceridine injection,
for the management of moderate-to-severe acute pain, TRV250 for the
treatment of acute migraine, and TRV734 for pain. The Company
maintains an early stage portfolio of drug discovery programs.
Cautionary note on forward looking
statements
Any statements in this press release about future expectations,
plans and prospects for the Company, including statements about the
Company’s strategy, future operations, clinical development of its
therapeutic candidates, plans for potential future product
candidates and other statements containing the words “anticipate,”
“believe,” “estimate,” “expect,” “intend,” “may,” “plan,”
“predict,” “project,” “suggest,” “target,” “potential,” “will,”
“would,” “could,” “should,” “continue,” and similar expressions,
constitute forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. Actual results
may differ materially from those indicated by such forward-looking
statements as a result of various important factors, including: the
status, timing, costs, results and interpretation of the Company’s
clinical trials or any future trials; the uncertainties inherent in
conducting clinical trials; interpretations of regulatory
interactions and expectations for regulatory submissions and
approvals, including whether the; availability of funding
sufficient for the Company’s foreseeable and unforeseeable
operating expenses and capital expenditure requirements;
uncertainties related to the Company’s intellectual property; other
matters that could affect the availability or commercial potential
of the Company’s therapeutic candidates; and other factors
discussed in the Risk Factors set forth in the Company’s Annual
Report on Form 10-K and Quarterly Reports on Form 10-Q filed with
the Securities and Exchange Commission (SEC) and in other filings
the Company makes with the SEC from time to time. In addition, the
forward-looking statements included in this press release represent
the Company’s views only as of the date hereof. The Company
anticipates that subsequent events and developments may cause the
Company’s views to change. However, while the Company may elect to
update these forward-looking statements at some point in the
future, it specifically disclaims any obligation to do so, except
as may be required by law.
Contacts
Trevena, Inc.
Investors:
Jonathan Violin, Ph.D.Senior Vice President, Scientific Affairs
& Investor Relations Officer610-354-8840
x231jviolin@trevena.com
or
Media:
Public RelationsPR@trevena.com
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