Full Press Release Details
Results from Respiratory Physiology Study of Head-to-Head Comparison of OLINVYK and IV Morphine in Elderly/Overweight Subjects
a statistically significant reduced impact on respiratory function compared to IV morphine, among elderly/overweight subjects
observations previously seen in a comparative study of respiratory physiology in younger subjects with OLINVYK and IV morphine
April 20, 2022 (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 results from its double
blinded, crossover study evaluating OLINVYK (oliceridine) injection for the management of acute pain, in elderly/overweight. This
study builds on the collaborative work with Dr. Albert Dahan and his research team at Leiden University Medical Center (LUMC).
pleased with the results of our study, which replicate earlier results reported in younger subjects", said Dr. Albert Dahan, Professor
of Anesthesiology at Leiden University Medical Center, "These data suggest that OLINVYK, a new chemical entity, may offer a more
favorable respiratory safety profile when compared to IV morphine."
team compared the analgesic and respiratory effects of two doses of OLINVYK (0.5mg and 2.0mg) and morphine (2.0mg and 8.0mg) administered
intravenously in a population of elderly individuals (age range 56 to 87 years, mean age = 71.2) across a range of body weight (BMI range
from 20 to 34 kg/m2, mean BMI= 26.3). Subjects were tested on 4 occasions and randomized by drug and dose. On each visit,
the ventilatory response to inhaled carbon dioxide was measured to evaluate the potential effect of the drug on the brain respiratory
centers. Elderly and overweight patients are known to be at higher risk of respiratory depression with the use of opioid medications.
This study hypothesized that, at similar levels of analgesia, there would be a reduced impact on respiratory function with OLINVYK compared
to IV morphine. The primary endpoint of the study was ventilatory rate at an extrapolated PCO2 of 55 mmHg (VE55).
these data from Dr. Dahan's study team are important. They replicate the results from an earlier study reported by Trevena in younger
subjects using a similar methodology, and they extend our knowledge to patients who are at higher risk for the development of respiratory
depression with the use of opioids, namely elderly and overweight patients," said Mark A. Demitrack, M.D., Senior Vice President
and Chief Medical Officer of Trevena. "As with all opioids, serious, life-threatening, or fatal respiratory depression may occur
in patients treated with OLINVYK. We look forward to seeing further analysis of this data by Dr. Dahan's team and working with
him to see these results reported to the wider scientific community and submitted for publication in the near future."
About OLINVYK (oliceridine)
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.
NEONATAL 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.
RISK 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 are inadequate.
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 with:
WARNINGS AND PRECAUTIONS
Adverse reactions are described in greater detail in the Prescribing
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 four differentiated investigational drug candidates: TRV045 for diabetic neuropathic
pain and epilepsy, TRV027 for acute respiratory distress syndrome and abnormal blood clotting in COVID-19 patients, TRV250 for the acute
treatment of migraine and TRV734 for maintenance treatment of opioid use disorder.
For more information, please visit www.Trevena.com
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 and trials 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 or any future trials of any of the Company's investigational
drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and
approvals, including the Company's assessment of discussions with FDA; available funding; uncertainties related to the Company's
intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial
potential of the Company's therapeutic candidates and approved product; 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.
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