Trevena Announces Publication of APOLLO-2 Results in Pain Practice
June 24 2019 - 07:00AM
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 announced publication of APOLLO-2 (pivotal Phase
3) results in Pain Practice on the effects of oliceridine (TRV130)
for management of moderate-to-severe acute pain following
abdominoplasty.
The publication: “APOLLO-2: A Randomized, Placebo and
Active-Controlled Phase III Study Investigating Oliceridine
(TRV130), a G Protein-Biased Ligand at the µ-Opioid Receptor, for
Management of Moderate to Severe Acute Pain Following
Abdominoplasty”, with lead author, Neil Singla, M.D., CEO of Lotus
Clinical Research, is available online at
https://doi.org/10.1111/papr.12801.
“IV opioids remain an important option for physicians in
managing post-surgical moderate to severe acute pain for a subset
of patients. In this study, oliceridine provided
statistically superior pain relief compared to placebo, with a
rapid onset of action and a favorable safety profile,” said Dr.
Singla. “These results are consistent with those seen in the
APOLLO-1 pivotal Phase 3 study in bunionectomy patients, suggesting
that oliceridine is efficacious and well-tolerated, and could
provide pain relief for patients with moderate to severe acute
pain.”
Study Summary and Key findings:
- In APOLLO-2, a Phase 3 randomized, double-blind, placebo- and
active-controlled clinical study, 401 patients were administered
either oliceridine, morphine, or placebo intravenously (IV) for 24
hours following abdominoplasty.
- There were three dosing regimens for oliceridine (0.1mg,
0.35mg, and 0.5mg) and one for morphine (1mg), each
self-administered by the patient as needed to control their
pain.
- The primary endpoint of the study was achieved: the proportion
of treatment responders in all the oliceridine treatment regimens
was statistically significantly superior to placebo.
- Findings showed that the onset of analgesia with oliceridine
was rapid, and the proportion of treatment responders in the two
higher oliceridine dosing regimens was similar to patients
receiving morphine.
- The most commonly reported adverse events (AEs) in the study
were nausea, vomiting, somnolence, and headache.
- The proportion of patients experiencing a respiratory safety
event was lower in all oliceridine treatment groups compared to
morphine, though this difference did not reach statistical
significance.
- The efficacy, safety and tolerability data from this study are
consistent with those seen in prior published clinical studies of
IV oliceridine and suggest that oliceridine may represent an
important new therapeutic alternative for the treatment of patients
with moderate-to-severe acute pain where an IV opioid is
warranted.
About Oliceridine
Oliceridine is a G protein biased (selective) 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 expects that oliceridine will be
classified as a Schedule II controlled substance.
About Trevena
Trevena, Inc. is a biopharmaceutical company focused on the
development and commercialization of novel medicines for patients
with Central Nervous System (CNS) conditions. 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
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; 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, including whether IV opioids remain a necessary
medication for many hospital patients and whether oliceridine might
become a new option or clinically important alternative to help
hospitals and healthcare providers better manage their patients’
pain; 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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