Full Press Release Details
Initial Topline OLINVYK Data from
Real-World Clinical Outcomes Study
patients had a statistically significant 1.6 day (~27%) reduction in average overall hospital length of stay compared to matched patients
treated with other IV opioids, based on initial EMR analysis of ARTEMIS patients at Wake Forest Baptist Health
patients had a 52.2% GI complete responder rate, defined as no vomiting and no antiemetic use throughout the post-operative period, based
on initial topline data from the VOLITION (n=203) real world outcomes study
Over 90% of OLINVYK-treated
patients in VOLITION reported feeling "alert and calm" from the morning of the first post-operative day and at every observation
point thereafter, based on the Richmond Agitation-Sedation Scale
OLINVYK-treated patients in VOLITION exhibited symptoms suggestive of delirium at any point in the 48-hour post-operative observation
point, based on 3D-CAM assessment
CHESTERBROOK, Pa., March 30, 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 initial topline OLINVYK data from two related
real-world outcomes studies: VOLITION and ARTEMIS.
The VOLITION study (n=203 patients),
a real-world, open-label, multi-site study, assessed the potential impact of OLINVYK on respiratory, gastrointestinal (GI), and cognitive
function outcomes in the postoperative setting, and was led by clinical outcomes research experts from the Cleveland Clinic and the Wake
Forest Baptist Health Medical Center. Initial GI and cognition data are available, with respiratory outcome data expected mid-2023.
The ARTEMIS study was an electronic
medical records (EMR) based assessment focused on clinical and health resource utilization outcomes. The study reviewed OLINVYK-treated
patients in the VOLITION study with comparable surgical patients treated with other IV opioids, at the same institutions and during the
same general time period. Initial ARTEMIS data from Wake Forest Baptist Health is currently available, representing 96 OLINVYK-treated
patients and 457 matched patients treated with other IV opioids.
VOLITION Preliminary Topline Results
ARTEMIS (EMR-Based) Initial Results
from Wake Forest Baptist Health
Patients receiving any IV
opioid who experienced delirium or altered consciousness in this study had an average hospital length of stay 10.5 days longer than patients
who did not experience this event. ICD-coding was used for this comparative analysis as 3D-CAM is not generally used in the general patient
VOLITION and ARTEMIS 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 an 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).
ARTEMIS is an 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.
OLINVYK (oliceridine) injection
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.
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.
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
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