Trevena Announces Publication of Results from Phase 3 “Real World” Safety Study for Oliceridine in The Journal of Pain Re...
20 November 2019 - 11:00PM
Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused
on the development and commercialization of novel medicines for
patients with central nervous system (CNS) disorders, today
announced publication of results from the Phase 3 open-label safety
study (ATHENA) for IV oliceridine in The Journal of Pain Research.
The results highlight the safety and tolerability of oliceridine in
the management of moderate-to-severe acute pain in a variety of
surgical / medical settings and patient populations.
The publication, “ATHENA: A Phase 3, Open Label Study of the
Safety and Effectiveness of Oliceridine (TRV130), a G-Protein
Selective Agonist at the µ-Opioid Receptor, in Patients with
Moderate to Severe Acute Pain Requiring Parenteral Opioid Therapy”
with investigator and lead author, Sergio Bergese, M.D., Department
of Anesthesiology, School of Medicine, Stony Brook University, is
available online on Dove Medical Press.
“The results of this study show that oliceridine was generally
safe and well-tolerated in a variety of surgical and medical
conditions with acute pain. Additionally, oliceridine performed
consistently in the patient population studied, including elderly
and obese patients, who are at greater risk for developing
opioid-related adverse effects,” said Dr. Bergese. “These findings
suggest that oliceridine may represent a potential new treatment
option for the management of moderate-to-severe acute pain where IV
opioid therapy is warranted.”
Study Summary and Key Findings:
- This was a Phase 3, multi-center, open-label study that
evaluated the safety of oliceridine in 768 patients with
moderate-to-severe acute pain. It was conducted in 41 sites in the
United States, including ambulatory surgical centers,
hospital-based outpatient and inpatient settings, and emergency
departments.
- In order to study oliceridine in a broad, “real world” context
where IV analgesics are typically used, the protocol was designed
with broader patient eligibility criteria, concomitant treatment
allowances, and mode of administration (both clinician-directed
bolus and patient-controlled analgesia were permitted as clinically
indicated).
- The average age of patients in this study was 54 years. 32% of
patients were 65 years or older, and 46% were considered obese with
a body mass index (BMI) of 30 kg/m2 or higher. The study included
patients with a range of co-morbidities, including diabetes,
chronic / cancer pain and obstructive sleep apnea.
- Patients with post-surgical acute pain comprised the majority
of the study population (94%). The most common procedure types were
orthopedic (30%), colorectal (15%) and gynecological (15%).
- AEs were mostly of mild or moderate severity, and only 2% of
patients discontinued treatment due to an AE. The most commonly
reported adverse events (AEs) were nausea, vomiting, and
constipation.
About Oliceridine
Oliceridine is a G protein biased (selective) mu-opioid receptor
ligand in development for the management of moderate to severe
acute pain in hospitals or other controlled clinical settings where
intravenous 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 disorders. 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.
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 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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