Trevena Advances NDA Resubmission Activities for Oliceridine
August 28 2019 - 3:01PM
Trevena, Inc. (Nasdaq: TRVN), a
biopharmaceutical company focused on the development and
commercialization of novel medicines for patients with Central
Nervous System (CNS) conditions, today provided an update on the
activities to support resubmission of the New Drug Application
(NDA) for oliceridine.
The Company has completed enrollment for the ongoing healthy
volunteer QT study and remains on track to support topline data
readout in the fourth quarter of 2019.
In addition, the Company has completed the necessary nonclinical
work to further characterize the 9662 inactive metabolite. As
agreed to with FDA, the Company has generated reproducible
pharmacokinetic data using validated bioanalytical methods that
demonstrate acceptable levels of exposure to the metabolite in
nonclinical species.
Lastly, the Company has finished the outstanding drug product
validation reports identified in the Complete Response Letter
(CRL), which will be included in the NDA resubmission
package.
“We continue to make steady progress on all fronts to
gather the information needed to resubmit the NDA for oliceridine,”
said Carrie Bourdow, President and Chief Executive Officer.
“I am pleased that we have finished the work to address three
of the four items outlined in the CRL. Once we receive
topline data for the healthy volunteer QT study, which we are on
schedule to report next quarter, we look forward to resubmitting
the NDA as early as possible in the first quarter of next
year.”
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 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, nonclinical studies, 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, and whether
there is a path to resubmit the oliceridine NDA; 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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