Trevena Announces Submission of New Drug Application to U.S. FDA for OLINVO™ (oliceridine injection)
November 02 2017 - 7:00AM
Trevena, Inc. (NASDAQ:TRVN) today announced that it has recently
submitted its New Drug Application (NDA) for OLINVOTM (oliceridine
injection) to the U.S. Food and Drug Administration (FDA).
OLINVO is the first G protein biased ligand of the mu opioid
receptor, a new class of opioid receptor modulator, and the first
pain program to receive Breakthrough Therapy designation from the
FDA.
The submission includes data showing that intravenous OLINVO
demonstrated analgesic efficacy in all three dosing regimens tested
in the two Phase 3 APOLLO pivotal efficacy studies. These
trials were designed to support an indication for the management of
moderate-to-severe acute pain in adult patients for whom an
intravenous opioid is warranted.
The filing also includes safety and tolerability data for over
1,100 patients administered OLINVO across Phase 2 and Phase 3
studies, including the ATHENA open label safety study.
Additional pharmacokinetic data, clinical pharmacology data, and
results from five randomized controlled trials with head to head
comparisons to morphine support potential differentiation of
OLINVO.
“OLINVO was designed to fill a major gap in the set of medicines
available for managing moderate to severe pain in the hospital,”
said Maxine Gowen, Ph.D., chief executive officer. “Despite
availability of non-opioid analgesics and advances in multimodal
analgesia, tens of millions of patients still require IV opioids
following surgery, during severe illness, or after trauma.
Millions of these patients remain at risk for opioid-related
adverse events, including respiratory depression or postoperative
vomiting. We look forward to working with the FDA during the
review process and to a potential NDA approval of OLINVO in
2018.”
About OLINVO™ (oliceridine injection)
OLINVO is a 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 FDA.
OLINVO was specifically designed to improve conventional opioid
pharmacology to deliver the pain-reducing potential of an opioid
but with fewer associated adverse effects via its biased ligand
mechanism of action. In Phase 2 and Phase 3 clinical trials, OLINVO
provided rapid and powerful analgesic efficacy while demonstrating
a wider therapeutic window compared to morphine, suggesting it may
be highly effective and well-tolerated for patients in need of
strong analgesia. OLINVO is an investigational product and has not
been approved by the FDA or any other regulatory agency. The
Company expects OLINVO to be a Schedule II controlled
substance.
About Trevena
Trevena, Inc. is a biopharmaceutical company focused on
providing better, safer therapies to patients in pain. The
Company has leveraged breakthrough science to discover and develop
its investigational product OLINVO for the management of
moderate-to-severe acute pain. The Company has an early stage
pipeline of new chemical entities targeting novel mechanisms of
action, including for acute migraine, neuropathic pain, and other
indications.
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; the uncertainties inherent in conducting clinical
trials; expectations for regulatory approvals, including with
respect to the OLINVO NDA; 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
Investors: Jonathan Violin, Ph.D. Vice
President, Corporate Strategy & Investor Relations 610-354-8840
x231 jviolin@trevena.com
Media: Public Relations PR@trevena.com
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