Full Press Release Details
New Topline OLINVYK Data Highlighting
per Admission from ARTEMIS Real-World Outcomes Study
patients (n=201) had a statistically significant ~$8,750 (19%) lower cost per admission and ~1.4 day (20%) reduced average length of
hospital stay, compared to matched patients treated with other IV opioids (n=982)
data from VOLITION ~200 patient real-world outcomes study using continuous respiratory monitoring expected 3Q 2023
CHESTERBROOK, Pa., June 26, 2023 (GLOBE
NEWSWIRE) -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 new topline OLINVYK data from the ARTEMIS study.
The ARTEMIS study was an electronic
medical records (EMR) based assessment focused on clinical and health resource utilization outcomes at Cleveland Clinic and Wake Forest
Baptist Health. The study reviewed OLINVYK-treated patients in the ~200 patient VOLITION study with comparable surgical patients (matched
patients) treated with other IV opioids, at the same institutions and during the study period.
New topline data includes data from
OLINVYK-treated patients (n=105) and matched patients (n=525) at Cleveland Clinic, as well as measures of cost per admission at both
Wake Forest Baptist Health and Cleveland Clinic for OLINVYK-treated and matched patients. Initial ARTEMIS data from Wake Forest Baptist
Health was previously announced based on OLINVYK-treated patients (n=96) compared to matched patients (n=457) at that site.
"We are pleased that the use of
OLINVYK versus other IV opioids demonstrated a statistically significant reduced cost per admission and a reduced average length of stay,
which we believe are important considerations as hospitals look to manage resources," said Carrie Bourdow, President and CEO of
Trevena. "These data are consistent with prior health economic analyses we have conducted, and we believe these differences will
be meaningful to key healthcare decision makers."
ARTEMIS (EMR-Based) Topline Results
ARTEMIS Study Details
ARTEMIS is an electronic medical record
(EMR) based analysis that compared the health outcomes of VOLITION study patients with a matched population of patients, who underwent
similar surgical procedures but were treated with other IV opioids, at the same institutions and during the same general time period
as VOLITION. Matching was conducted with a greedy matching algorithm, using a propensity scoring method with eight different demographic
and clinical characteristics including age, sex, type and duration of surgery, measures of overall surgical and medical morbidity, and
type of hospital insurance. Cost weights were calculated using a national dataset, and data was controlled for relevant covariates.
The Company previously announced initial
topline ARTEMIS data from Wake Forest Baptist Health (n=96 OLINVYK-treated patients; n=457 matched patients treated with other IV opioids).
New topline data is now available from Cleveland Clinic (n=105 OLINVYK-treated patients; n=525 matched patients treated with other IV
opioids), as well as for cost per admission for both Wake Forest Baptist Health and Cleveland Clinic.
While an EMR analysis
does not provide definitive data of group differences as seen in a prospectively randomized study, we believe EMR data bring a unique
perspective to an understanding of how drugs may perform in the real world.
VOLITION Study Details
VOLITION is a real-world, open-label,
multi-site, post-approval clinical outcomes study in 203 adult patients undergoing major non-cardiac surgery. IV OLINVYK was dosed as
the first-line analgesic during post-operative care, with a 1.5mg loading dose of OLINVYK at surgical closure, and 0.35mg to 0.5mg of
OLINVYK, as needed, administered with a PCA device, with a 6-minute lockout period. Additional boluses ( 1 mg) of OLINVYK were available
if needed as soon as 15 minutes after the initial 1.5 mg loading dose.
The average age of patients in VOLITION
was 57.1 years (range 19 to 89), with approximately equal representation of men and women. Approximately 85% of patients underwent an
abdominal surgical intervention, such as partial or total colectomy, enterotomy or other open abdominal procedures. A majority of patients
had significant morbidity at the time of surgery as reflected by ASA status, and their respiratory risk was intermediate to high risk,
graded using the PRODIGY risk score. The average duration of the surgery was 4.7 hours (range of 1.2 to 12.6 hours).
About OLINVYK (oliceridine)
OLINVYK is a new chemical
entity approved by the FDA in August 2020. OLINVYK contains oliceridine, an opioid, which is a Schedule II controlled substance with
a high potential for abuse similar to other opioids. It is indicated in adults for the management of acute pain severe enough to require
an intravenous opioid analgesic and for whom alternative treatments are inadequate. OLINVYK is available in 1 mg/1 mL and 2 mg/2 mL single-dose
vials, and a 30 mg/30 mL single-patient-use vial for patient-controlled analgesia (PCA). Approved PCA doses are 0.35 mg and 0.5 mg and
doses greater than 3 mg should not be administered. The cumulative daily dose should not exceed 27 mg. Please see Important Safety Information,
including the BOXED WARNING, and full prescribing information at www.OLINVYK.com.
ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT
USE WITH BENZODIAZEPINES OR OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS
ABUSE, AND MISUSE - OLINVYK exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can
lead to overdose and death. Assess each patient's risk before prescribing OLINVYK, and monitor all patients regularly for the development
of behaviors or conditions.
RESPIRATORY DEPRESSION - Serious, life-threatening, or fatal respiratory depression may occur with use of OLINVYK. Monitor
for respiratory depression, especially during initiation of OLINVYK or following a dose increase.
OPIOID WITHDRAWAL SYNDROME - Prolonged use of OLINVYK during pregnancy can result in neonatal opioid withdrawal syndrome, which
may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts.
If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome
and ensure that appropriate treatment will be available.
FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS - Concomitant use of opioids with benzodiazepines or other
CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing
for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow
patients for signs and symptoms of respiratory depression and sedation.
INDICATIONS AND USAGE
OLINVYK is an opioid agonist indicated
in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments
Because of the risks of addiction, abuse,
and misuse with opioids, even at recommended doses, reserve OLINVYK for use in patients for whom alternative treatment options [e.g.,
non-opioid analgesics or opioid combination products]:
The cumulative total daily dose should
not exceed 27 mg, as total daily doses greater than 27 mg may increase the risk for QTc interval prolongation.
OLINVYK is contraindicated in patients
WARNINGS AND PRECAUTIONS
Adverse reactions are described in greater
detail in the Prescribing Information.
The most common (incidence 10%)
adverse reactions in Phase 3 controlled clinical trials were nausea, vomiting, dizziness, headache, constipation, pruritus, and hypoxia.
For medical inquiries or to report an
adverse event, other safety-related information or product complaints for a company product, please contact the Trevena Medical Information
Contact Center at 1-844-465-4686 or email MedInfo@Trevena.com.
You are encouraged to report suspected
adverse events of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information,
including Boxed Warning.
Trevena, Inc. is a biopharmaceutical
company focused on the development and commercialization of innovative medicines for patients with CNS disorders. The Company has one
approved product in the United States, OLINVYK (oliceridine) injection, indicated in adults for the management of
acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company's
novel pipeline is based on Nobel Prize winning research and includes three differentiated investigational drug candidates: TRV045 for
diabetic neuropathic pain and epilepsy, TRV250 for the acute treatment of migraine and TRV734 for maintenance treatment of opioid use
For more information, please visit www.Trevena.com
this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy,
future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates and other