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Trevena Reports Fourth Quarter 2022 Results and Provides Business Update Company announces initial topline OLINVYK data including GI and cognitive outcomes, and length of stay data from ~200 patient real-world clinical o

Key Takeaway: Trevena Reports Fourth Quarter 2022 Results and Provides Business Update Company announces initial topline OLINVYK data including GI and cognitive outcomes, and length of stay data from ~200 patient real-world clinical outcomes study TRV045, a novel S1P receptor modulator, co

Full Press Release Details

Trevena Reports Fourth Quarter 2022 Results
and Provides Business Update
Company announces initial topline OLINVYK data
including GI and cognitive outcomes, and length of stay data from ~200 patient real-world clinical outcomes study
TRV045, a novel S1P receptor modulator, continues
to advance as a potential treatment for epilepsy, diabetic neuropathic pain and other CNS disorders, with two proof-of-concept studies
expected to complete enrollment by mid-2023
Cash balance of $38.3 million at year end 2022
Company to host conference call today, March
30, 2023 at 8:00 a.m. ET
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 reported its financial results for the fourth quarter ended December 31, 2022 and provided
an overview of its recent operational highlights.
"We are excited to report initial topline data from the OLINVYK
real-world outcomes studies, VOLITION and ARTEMIS. The GI and cognitive results build upon the extensive data set for OLINVYK, and we
look forward to reporting respiratory outcome data as soon as it is available." said Carrie Bourdow, President and CEO of Trevena.
"We are also pleased to now have two proof-of-concept studies underway for TRV045, and we expect to report top-line data later this
Fourth Quarter 2022 and Recent Corporate Highlights
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, and only 3.9% of OLINVYK-treated patients
exhibited symptoms suggesting delirium at any point in the 48-hour post-operative period, based on the validated 3D-Confusion
Assessment Method (3D-CAM) screening tool. Sedation is an established risk of opioids including OLINVYK. Analysis of respiratory data
from VOLITION is not yet available, and the Company expects to report these data mid-2023.
Both studies are expected to complete enrollment by mid-2023,
and the Company expects to report top-line data in 3Q 2023
Financial Results for Fourth Quarter 2022
For the fourth quarter of 2022, the Company reported a net loss attributable
to common stockholders of $7.0 million, or $0.73 per share, compared to $14.0 million, or $2.12 per share in the fourth quarter of 2021.
For the full year ended December 31, 2022, net loss attributable to common stockholders was $53.7 million, or $7.59 per share, compared
to $51.6 million, or $7.90 per share.
Cash and cash equivalents were $38.3 million as of December 31, 2022,
which the Company believes will be sufficient to fund the Company's operating expenses and capital expenditure requirements into
the fourth quarter of 2023.
Conference Call and Webcast Information
The Company will host a conference call and webcast with the investment
community on March 30, 2023, at 8:00 a.m. Eastern Time featuring remarks by Carrie Bourdow, President and Chief Executive Officer, Patricia
Drake, Chief Commercial Officer, Mark Demitrack, M.D., Senior Vice President and Chief Medical Officer, and Barry Shin, Chief Financial
Title: Trevena Third Quarter 2022 Financial Results Conference Call & Webcast
Date: Thursday, March 30, 2023
Time: 8:00 a.m. ET
Conference Call Details: Toll-Free: 1-877-704-4453 International: 1-201-389-0920 Conference ID: 13736610
The conference call will be webcast live from the Company's website and will be available via the following links:
Webcast:
webcast should be accessed 15 minutes prior to the conference call start time. A replay of the webcast will be available following
the conclusion of the live broadcast and will be accessible on the Company's website.
OLINVYK (oliceridine) injection
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
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 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:
Significant respiratory depression
Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
Known or suspected gastrointestinal obstruction, including paralytic ileus
Known hypersensitivity to oliceridine (e.g., anaphylaxis)
WARNINGS AND PRECAUTIONS
OLINVYK contains oliceridine, a Schedule II controlled substance, that exposes users to the risks of addiction, abuse, and misuse. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed OLINVYK. Assess risk, counsel, and monitor all patients receiving opioids.
Serious, life-threatening respiratory depression has been reported with the use of opioids, even when used as recommended, especially in patients with chronic pulmonary disease, or in elderly, cachectic and debilitated patients. The risk is greatest during initiation of OLINVYK therapy, following a dose increase, or when used with other drugs that depress respiration. Proper dosing of OLINVYK is essential, especially when converting patients from another opioid product to avoid overdose. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient's clinical status.
Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia with risk increasing in a dose-dependent fashion. In patients who present with CSA, consider decreasing the dose of opioid using best practices for opioid taper.
Prolonged use of opioids during pregnancy can result in withdrawal in the neonate that may be life-threatening. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using OLINVYK for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
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.
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.
TRV045 is a novel, selective sphingosine-1-phosphate
subtype 1 (S1P1) receptor modulator being developed as a potential treatment for acute and chronic neuropathic pain secondary
to diabetic peripheral neuropathy. Through a collaboration with the National Institutes of Health, Trevena is also exploring TRV045 as
a potential treatment for epilepsy.
S1P receptors are located throughout the body,
including the central nervous system, where they are believed to play a role in modulating neurotransmission and membrane excitability.
Trevena's discovery efforts have identified a
family of compounds that are highly selective for the S1P1 receptor. TRV045 reversed thermal hyperalgesia, a measure of neuropathic
pain, in nonclinical models of diabetic peripheral neuropathy and chemotherapy-induced peripheral neuropathy. TRV045 was not associated
with lymphopenia and produced no changes in blood pressure, heart rate, or respiratory function at or above pharmacologically active doses
in nonclinical studies. TRV045 is an investigational product and is not yet approved by the FDA.
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
Last updated: Mar 30, 2023