Trevena Announces Presentations at the American Society of Anesthesiologists 2019 Annual Meeting
October 21 2019 - 10:30AM
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 four presentations at ANESTHESIOLOGY®
2019, the national conference for the American Society of
Anesthesiologists, held at the Orange County Convention Center in
Orlando, Florida, October 19-23. The presentations included
one oral presentation and three posters, all of which discussed the
safety profile of oliceridine.
“IV opioids remain an effective treatment option for physicians
in managing moderate-to-severe acute pain following surgery.
However, opioid-related adverse effects – most notably respiratory
depression – can interfere with a drug’s analgesic efficacy and
complicate a patient’s recovery,” said Albert Dahan, M.D.,
Professor of Anesthesiology at the Leiden University Medical
Center. “Because there are no generally agreed standard
definitions for respiratory depression, our group has devoted
attention to improving the quantitative assessment of respiratory
depression in controlled clinical settings for various opioid
medications. We applied this technique, called clinical
utility function analysis, to available data for oliceridine, and I
was pleased to present the intriguing results of that analysis at
this year’s conference.”
Dr. Dahan presented the findings from a clinical utility
function analysis of the ventilatory response to hypercapnia data
from the Phase 1 proof-of-concept study comparing oliceridine to IV
morphine in healthy human volunteers. The oral presentation,
titled “Improved safety of opioid analgesic Oliceridine compared to
Morphine assessed by utility function analysis,” was part of the
Best of Abstracts: Clinical Science featured session.
In addition, three poster presentations featured safety and
tolerability data from the Phase 3 pivotal trials (APOLLO 1 /
APOLLO 2) and “real-world use” open-label safety study (ATHENA) for
oliceridine:
- Low Incidence Of Opioid-induced Respiratory Depression Observed
With Oliceridine Regardless Of Age Or Body Mass Index (Brzezinski,
M. et al) (e-poster, abstract #2228)
- Lower Incidence Of Postoperative Opioid-induced Respiratory
Depression With Oliceridine Compared To Morphine: A Retrospective
Analysis (Bergese, S. et al) (e-poster, abstract #2232)
- Oliceridine (TRV130) Demonstrates Less Opioid-induced
Respiratory Depression Than Morphine (M) As Measured By The Average
Cumulative Duration Of Dosing Interruption In Patients Being
Treated For Acute Post-surgical Pain (Ayad, S. et al) (e-poster,
abstract #3069)
About OliceridineOliceridine 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 CNS
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 Soss
KCSA Strategic Communications Phone: 212-896-1254 / 212-896-1267
Email: IR@trevena.com
Company Contact: Bob Yoder, SVP and Chief
Business Officer Trevena, Inc. Phone: 610-354-8840
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