– Results presented from the successful APOLLO-1
Phase 3 pivotal efficacy study of OLINVOTM (oliceridine injection)
in moderate-to-severe acute pain –
Trevena, Inc. (NASDAQ:TRVN) today announced multiple data
presentations during the 36th Annual Scientific Meeting of the
American Pain Society (APS) being held at the David L. Lawrence
Convention Center in Pittsburgh, Pennsylvania, May 17 - 20. The
presentations highlight preclinical and clinical data for OLINVOTM
(oliceridine injection), Trevena’s Breakthrough Therapy-designated
investigational product for the management of moderate-to-severe
acute pain, and include recently-released results from the
successful Phase 3 APOLLO-1 pivotal efficacy study in postsurgical
pain. The presentations also feature results from new preclinical
studies of OLINVO’s novel mechanism of action at the µ-opioid
receptor suggesting that OLINVO and molecules like it may avoid
triggering opioid-induced hyperalgesia which, research has shown,
may prolong and exacerbate pain in patients treated with
conventional opioids.
“OLINVO was designed to improve opioid pharmacology by
harnessing groundbreaking discoveries in how opioid receptors
work,” said Neil Singla, M.D., chief scientific officer at Lotus
Clinical Research and the coordinating investigator for the APOLLO
trials. “The basic research, preclinical development, and
clinical trials have all consistently shown that OLINVO may provide
pain relief comparable to that of conventional opioids with the
potential for reduced frequency of costly and dangerous
opioid-related gastrointestinal and respiratory adverse
effects. New data suggesting the OLINVO mechanism also may
avoid or even reverse opioid-induced hyperalgesia is yet another
exciting indication that OLINVO may be a valuable new option for
patients who require IV opioids but are at risk for poor outcomes
caused by opioid-related adverse effects.”
Oral presentations: Tuesday, May 16th, 3:30 - 4:30 p.m.
EDT
Michael Lark, Ph.D., chief scientific officer of Trevena, and
David Soergel, M.D., chief medical officer of Trevena, presented
preclinical and clinical data, respectively, from the OLINVO
program as part of a panel entitled “Biased ligands: Is basic
science finally starting to pay off?” at the Spring Pain 2017
research conference running in partnership with APS. Their
presentations highlighted the basic science and potential
advantages of biased ligands as a new class of analgesics.
Poster presentations:
Title: APOLLO-1: randomized, placebo- and active-controlled
phase 3 study investigating oliceridine (TRV130), a novel μ
receptor G protein Pathway Selective (μ-GPS) modulator, for
management of moderate to severe acute pain following
bunionectomy
Poster Number: 223
Poster Session: Thursday, May 18, 9:30 - 11:00 a.m. EDT
Title: Assessment of Nociceptive Sensitization with TRV0109101,
a Novel µ Receptor G Protein Pathway Selective Modulator (µ-GPS),
versus Fentanyl, Morphine, and Oxycodone
Poster Number: 224
Poster Session: Thursday, May 18, 3:45 - 5:15 p.m. EDT
About OLINVOTM (oliceridine
injection)
OLINVOTM (oliceridine injection) was granted Breakthrough
Therapy designation by the U.S. Food and Drug Administration (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. In Phase 2 and Phase 3
clinical trials to date, OLINVO provided rapid and powerful
analgesic efficacy while demonstrating a wider therapeutic window
compared with 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. If approved, the Company expects
OLINVO to be a Schedule II controlled substance.
About moderate-to-severe acute pain management in
hospitals
Pain management is essential for patient recovery and discharge
from hospitals and ambulatory surgery centers. Despite the
use of other approaches to pain relief, IV opioids often remain
necessary for treating moderate-to-severe pain: approximately 50
million hospital patients in the U.S. are treated each year with
conventional IV opioids. However these medications are associated
with important adverse effects: nausea and vomiting occur in
approximately 30% of postoperative patients and contribute
approximately $1 billion in U.S. hospital costs; opioid-induced
respiratory depression can threaten patient safety and accounts for
up to $28,000 in additional hospital costs per patient. This unmet
need is highest for patients whose pain management requires an IV
opioid but are at risk from opioid-induced respiratory depression,
may suffer surgical complications from post-operative vomiting, or
whose recovery may be prolonged by post-operative nausea and
vomiting.
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 OLINVO. Trevena also has
discovered TRV250, in early clinical development for the treatment
of 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
preclinical and clinical trials, including the interpretation of
the top-line results from the APOLLO trials, whether OLINVO may
avoid triggering or reverse opioid-induced hyperalgesia, whether
OLINVO may provide pain relief comparable to conventional opioids
with the potential for reduced frequency of costly and dangerous
opioid-related gastrointestinal and respiratory adverse effects,
and whether OLINVO may be a valuable new option for patients who
require IV opioids but are at risk for poor outcomes caused by
opioid-related adverse effects; the uncertainties inherent in
conducting clinical trials; expectations for regulatory approvals;
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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