Trevena Announces Receipt of Type A Meeting Minutes and Provides Regulatory Update for Oliceridine
January 28 2019 - 7:00AM
– Company announces initial path forward on
oliceridine NDA –
Trevena, Inc. (NASDAQ: TRVN) today announced the receipt of
the official Type A meeting minutes from the U.S. Food and Drug
Administration (FDA) regarding the Complete Response Letter (CRL)
received for the oliceridine New Drug Application (NDA).
FDA has agreed that the Company’s current safety database will
support labeling at a maximum daily dose of 27 mg.
FDA also has agreed that the Company can conduct a study in
healthy volunteers to collect the requested QT interval data and
that the study should include placebo- and positive-control
arms. The Company intends to submit a detailed protocol and
analysis plan to FDA shortly and, following receipt of FDA
feedback, anticipates initiating this study in the first half of
this year. The Company is not required to provide any
additional efficacy data to resubmit the oliceridine NDA.
“We are encouraged by the productive discussion with FDA, which
we believe has provided a path to resubmit the oliceridine NDA,”
said Carrie L. Bourdow, President and Chief Executive Officer.
“We remain committed to our mission of ensuring access to
safe and effective treatment options for hospital patients who
require an IV opioid to manage their moderate to severe acute
pain.”
To address other items in the CRL, FDA has indicated that the
Company should include supporting nonclinical data related to the
characterization of the 9662 metabolite and the remaining product
validation reports when the oliceridine NDA is resubmitted.
The Company also announced that it expects cash, cash
equivalents, and marketable securities as of December 31, 2018 to
be approximately $61.5 million, which the Company anticipates will
be sufficient to fund operating expenses and capital expenditure
requirements into the second quarter of 2020. In March 2019, the
Company expects to announce full financial results for the fourth
quarter and full year ended December 31, 2018.
Conference Call and WebcastA conference call
and webcast will be held on January 28, 2019 at 8:30 a.m. ET. To
join the call, please dial in at (855) 465-0180 (conference ID:
3882155).
To join a live audio webcast of the call, please visit the
Investor Presentation section of the Company’s website. Following
the conclusion of the call, the webcast will be available for
replay for 30 days.
About OliceridineOliceridine is a G-protein
biased mu-opioid receptor (MOR) ligand in development for the
management of moderate to severe acute pain in hospitals or other
controlled clinical settings where intravenous (IV) therapy is
warranted. It is a new chemical entity with a novel mechanism of
action that enables more selective targeting of newly discovered
pathways with the potential for fewer side effects. Oliceridine is
an investigational product and has not been approved by the FDA or
any other regulatory agency. If approved, the Company has requested
that oliceridine be classified as a Schedule II controlled
substance.
About Trevena Trevena, Inc. is a
biopharmaceutical company focused on the development and
commercialization of new and innovative treatment options for
patients in pain. The Company has three novel and differentiated
investigational drug candidates, including IV oliceridine, for the
management of moderate to severe acute pain in hospitals, TRV250
for the treatment of acute migraine, and TRV734 for pain and/or
management of opioid dependence. In its preclinical programs,
Trevena is evaluating a set of novel S1P receptor modulators that
may offer a new, non-opioid approach to managing chronic pain.
Cautionary note on 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 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,
and the timing of any FDA review of the protocol for a future
oliceridine study; availability of funding sufficient for the
Company’s foreseeable and unforeseeable operating expenses and
capital expenditure requirements and whether cash, cash
equivalents, and marketable securities as of December 31, 2018 will
be sufficient to fund operating expenses and capital expenditure
requirements into the second quarter of 2020; 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.
ContactsBob Yoder610-354-8840Trevena, Inc.
Investors:ir@trevena.com
or
Media:pr@trevena.com
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