Trevena Announces Initiation of Healthy Volunteer Study for Oliceridine
June 20 2019 - 7:00AM
Trevena, Inc. (Nasdaq: TRVN) (“Trevena” or the
“Company”), a biopharmaceutical company focused on the development
and commercialization of novel medicines for patients with Central
Nervous System conditions, announced today that it has initiated
the healthy volunteer QT interval study for oliceridine, the
Company’s lead investigational drug candidate for the management of
moderate to severe acute pain. The Company remains on track
to report topline data in the fourth quarter of 2019 and currently
expects to resubmit the New Drug Application (NDA) for oliceridine
as early as possible in the first quarter of 2020.
“After receiving feedback from FDA on our proposed healthy
volunteer study protocol and statistical analysis plan in mid-May,
the team quickly finalized details to ensure a timely study start,”
said Carrie Bourdow, President and CEO. “I would like to
commend the team for the considerable work they have accomplished
to ensure that we reached this significant milestone on time, and
we look forward to completing the critical work ahead for a
successful resubmission of the oliceridine NDA.”
The primary objective of the study is to collect the additional
QT interval data requested by the U.S. Food and Drug Administration
(FDA) for the resubmission of the NDA for oliceridine. The
study will be performed in healthy volunteers at a single site as a
three-period crossover design. Each subject will be randomly
sequenced through all three study periods: oliceridine, placebo,
and moxifloxacin as a positive control. A short,
treatment-free washout occurs between each period.
Electrocardiograms for all subjects will be obtained in a rigorous
manner throughout the study. The Company plans to submit data
on approximately 60 healthy volunteers, and among this study
population, a minimum of 20 subjects will receive a cumulative dose
of 27 mg, the proposed maximum daily dose of oliceridine.
About TrevenaTrevena, Inc. is a
biopharmaceutical company focused on the development and
commercialization of novel medicines for patients with Central
Nervous System conditions. The Company has four novel and
differentiated investigational drug candidates, including IV
oliceridine, for the management of moderate to severe acute pain in
hospitals, TRV250 for the acute treatment of migraine, and TRV734
for maintenance treatment of opioid use disorder. The Company
has also identified TRV045, a novel S1P receptor modulator that may
offer a new, non-opioid approach to managing chronic pain.
Forward-Looking StatementsAny 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 and trials 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, including with respect to any future clinical study of
oliceridine; the uncertainties inherent in conducting clinical
trials; expectations for regulatory interactions, submissions and
approvals, including the Company’s assessment of the discussions
with FDA, whether there is a path to resubmit the oliceridine NDA,
the timeline for NDA resubmission; available funding ;
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.
For more information, please contact:
Investor Contact:Valter Pinto / Allison
SossKCSA Strategic CommunicationsPhone: 212-896-1254 /
212-896-1267Email: IR@trevena.com
Company Contact:Bob Yoder, SVP and Chief
Business OfficerTrevena, Inc.Phone: 610-354-8840
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