Trevena Inc【TRVN】株式ニュース

Trevena Announces Receipt of $15 Million Non-Dilutive Tranche and Provides General Business Update
$15 million tranche from ex-US royalty-based financing, triggered by first commercial sale of OLINVYK by Jiangsu Nhwa, Trevena’s partner in China

New OLINVYK respiratory data from VOLITION ~200 patient real-world outcomes study, using continuous respiratory monitoring, expected 3Q 2023

Three OLINVYK abstracts accepted for presentation at upcoming American Society of Anesthesiologists Meeting in 4Q 2023

Company to participate in upcoming HC Wainwright conference (September 11-13)

Company to Hold Conference Call on Wednesday, September 6 at 8 a.m. Eastern Time to discuss TRV045 Proof-of-Concept Data

CHESTERBROOK, Pa., Sept. 06, 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 receipt of a $15 million tranche under its non-dilutive ex-US royalty-based financing (the R-Bridge Financing). This tranche of funding was triggered by the first commercial sale of OLINVYK in China by Jiangsu Nhwa, the Company’s licensee in China. As previously announced, OLINVYK has been approved in China for use in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.

The $15 million tranche is in addition to the $28.1 million of cash and cash equivalents the Company previously reported as of June 30, 2023. As part of the R-Bridge Financing, Trevena may receive an additional $10 million upon achievement of either a commercial or financing milestone.

The Company also announced additional expected near-term milestones:

New VOLITION Respiratory Data for OLINVYK. The Company previously reported initial topline GI and delirium data from the ~200 patient OLINVYK VOLITION study, a real-world, open-label, multi-site study led by clinical outcomes research experts from Cleveland Clinic and Wake Forest Baptist Health Medical Center. Trevena expects to report new respiratory data from the study using continuous respiratory monitoring in 3Q 2023.
OLINVYK Abstracts Accepted at American Society of Anesthesiologists (ASA) 2023 Meeting. The Company has three abstracts accepted for presentation at ASA, which will be held in San Francisco from October 13th to the 17th. One abstract was selected for an oral presentation as a top research abstract. The abstracts are embargoed until the conclusion of the meeting and at which time they will be available at https://www.trevena.com/publications. “ARTEMIS, A Real-World Evidence Trial Examining the Use of Oliceridine, a Biased Agonist at the µ(Mu) Receptor, in Patients Requiring Post-Surgical Pain Control.” With lead author Todd L. Wandstrat, PharmD of Trevena, Inc.“Postoperative Vomiting With IV Oliceridine in Postoperative Recovery: A Single-group Prospective Cohort Study” with lead author Mark Demitrack, M.D of Trevena, Inc.“Antinociception Versus Neurocognitive Effect of Biased Mu-opioid Receptor Oliceridine Versus Morphine- Utility Function Analysis” with lead author Albert Dahan MD PhD of the Centre for Human Drug Research, Leiden, the Netherlands.
TRV045 Data. The Company today reported results from its Target Engagement (PainCart®) and TMS Proof-of-Concept studies. In addition, a nonclinical study of TRV045 is ongoing, focused on the potential of TRV045 to treat infantile spasms, a rare pediatric disorder. TRV045 is also being studied by the NIH’s Epilepsy Therapy Screening Program as a potential disease-modifying therapeutic for the prevention of seizures. Nonclinical data from both of these studies are expected 2H 2023.
Trevena to Participate in Investor Conference. The Company announces that members of management will participate in the HC Wainwright Global Investment Conference being held in-person and virtually in New York City on September 11-13. A link to the webcast will be available on the Events page of the Investors section of the Company’s website at: https://www.trevena.com/investors/events-presentations/ir-calendar
Conference Call and Webcast Information
The Company will host a conference call and webcast with the investment community on September 6, 2023 at 8:00 a.m. Eastern Time featuring remarks by Carrie Bourdow, President and Chief Executive Officer, Mark Demitrack, M.D., Senior Vice President and Chief Medical Officer, and Barry Shin, Chief Financial Officer.

Title: Trevena Business Update
Conference Call & Webcast
Date: Wednesday, September 6, 2023
Time: 8:00 a.m. Eastern Time
Conference Call Details: Toll-Free:1- 877-704-4453 International:1- 201-389-0920
Conference ID: 13740836

The conference call will be webcast live from the Company’s website and will be available via the following links:

Webcast:
https://viavid.webcasts.com/starthere.jsp?ei=1630911&tp_key=ea5c342481
https://www.trevena.com/investors/events-presentations/ir-calendar

The 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.

About 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 single 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.

IMPORTANT SAFETY INFORMATION
WARNING: 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

ADDICTION, 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.

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.

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.
LIMITATIONS OF USE
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]:

Have not been tolerated, or are not expected to be tolerated
Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
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.

CONTRAINDICATIONS
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.
Profound sedation, respiratory depression, coma, and death may result from the concomitant use of OLINVYK with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, or alcohol). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate, prescribe the lowest effective dose, and minimize the duration.
OLINVYK was shown to have mild QTc interval prolongation in thorough QT studies where patients were dosed up to 27 mg. Total cumulative daily doses exceeding 27 mg per day were not studied and may increase the risk for QTc interval prolongation. Therefore, the cumulative total daily dose of OLINVYK should not exceed 27 mg.
Increased plasma concentrations of OLINVYK may occur in patients with decreased Cytochrome P450 (CYP) 2D6 function or normal metabolizers taking moderate or strong CYP2D6 inhibitors; also in patients taking a moderate or strong CYP3A4 inhibitor, in patients with decreased CYP2D6 function who are also receiving a moderate or strong CYP3A4 inhibitor, or with discontinuation of a CYP3A4 inducer. These patients may require less frequent dosing and should be closely monitored for respiratory depression and sedation at frequent intervals. Concomitant use of OLINVYK with CYP3A4 inducers or discontinuation of a moderate or strong CYP3A4 inhibitor can lower the expected concentration, which may decrease efficacy, and may require supplemental doses.
Cases of adrenal insufficiency have been reported with opioid use (usually greater than one month). Presentation and sympt