Full Press Release Details
Trevena Announces Positive Topline OLINVYK Cognitive
Function Data and Provides General Business Update
OLINVYK demonstrated statistically significant
reduced impact on neurocognitive functioning vs IV morphine on primary endpoint
Successfully negotiated OLINVYK contract with
a large group purchasing organization (GPO) serving over 50% of US acute care providers and 20% of US ambulatory care providers
Novel S1P receptor modulator TRV045 for diabetic
neuropathic pain on track for completion of Phase 1 in 2H 2022
Strategic allocation of resources and cost reductions
reinforce key focus areas and extends cash runway to mid-2023
CHESTERBROOK, Pa., July 28, 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 reported positive topline results from its post-approval study designed to assess the impact
on cognitive function in subjects treated with OLINVYK compared to IV morphine. The Company also provided a general business update including
recent realignment of resources and cost reductions, as well as progress on the US commercial launch of OLINVYK and the Company's
"We are pleased to announce the positive topline cognitive function
data and a major contract win for OLINVYK," said Carrie Bourdow, President and CEO of Trevena. "We also remain focused on
advancing the clinical studies for TRV045, our novel S1P receptor modulator, and our recent corporate realignment will help us increase
financial flexibility to drive forward our strategic priorities."
Cognitive Function Study
OLINVYK was studied in a randomized, double-blind, placebo-controlled,
dose-ranging design, in collaboration with the Netherlands-based Center for Human Drug Research. Subjects received single intravenous
doses of OLINVYK 1 mg and 3 mg, or morphine 5 mg and 10 mg, or placebo, using a partial-block crossover design. A comprehensive battery
of neurocognitive and motor assessments was obtained following each blinded dose, which included measures of Sedation/Reaction Time, Visual
Tracking, Higher-order Cognitive Processing, Motor Function and Eye-Hand Coordination. Twenty-three healthy subjects participated in the
study, including 13 males and 10 females, with a median age of 26.
Overall, OLINVYK showed evidence of a reduced impact on neurocognitive
function compared to IV morphine.
Other secondary outcome measures, including visual tracking and higher-order
cognitive processing did not show statistical differences between OLINVYK and IV morphine. No serious adverse events were observed in
the study, and adverse events were generally assessed as mild.
"Neurocognitive function including sedation and postural instability
may have important consequences in the clinical care setting with the use of opioid medications." said Mark Demitrack, M.D. Chief
Medical Officer of Trevena. "Mitigating the impact of these adverse events may have important implications for length of stay and
other health economic outcomes."
Trevena General Business Updates
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.
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
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.
LIFE-THREATENING 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.
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 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 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