Trevena Announces Two OLINVYK® Abstracts Highlighting Safety Data Accepted at ANESTHESIOLOGY® 2021

Rhea-AI Summary

Trevena, Inc. (Nasdaq: TRVN) announced the acceptance of two abstracts at ANESTHESIOLOGY® 2021, focusing on the safety data from the OLINVYK (oliceridine) injection program. The conference, held from October 8 to 12 in San Diego, will feature a top research abstract and highlights from two e-posters. OLINVYK is FDA-approved for managing acute pain in adults requiring intravenous opioid analgesics. The company continues to emphasize the medical community's interest in OLINVYK's profile.

Positive

• Acceptance of two abstracts at ANESTHESIOLOGY® 2021 highlights company research efforts.
• Presentation of a top research abstract indicates strong interest in OLINVYK.

Negative

• None.

CHESTERBROOK, Penn., Aug. 30, 2021 (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 the acceptance of two abstracts at ANESTHESIOLOGY® 2021. Both abstracts highlight safety data from the OLINVYK (oliceridine) injection program. The meeting is sponsored by the American Society of Anesthesiologists and will be held on October 8^th to 12^th in San Diego, California.

“I am pleased to have the opportunity to present additional compelling data from the OLINVYK development program,” said Mark A. Demitrack, M.D., Senior Vice President and Chief Medical Officer of Trevena. “The selection of one of our posters as a top research abstract is encouraging and speaks to the continued interest from the medical community in OLINVYK’s unique profile.”

Poster details:

• E-Poster #1: "Elevated Body Mass Index Does Not Affect Adverse Events Associated With Oliceridine, An Intravenous Opioid Agonist" with lead author Joseph F. Answine, M.D., Assistant Professor of Anesthesiology, Penn State Health Milton S. Hershey Medical Center.
  
  
  • Selected by the Committee on Scientific Advisory to be included in a special in-person poster session on October 9^th.
• E-Poster #2: “Safety Of Intravenous Oliceridine In Patients With Renal Impairment: Findings From A Phase 3 Open-label Study” with lead author Ashraf S. Habib, M.D., Professor of Anesthesiology, Duke University School of Medicine.
  

The posters are embargoed until the date and time of presentation. Upon conclusion of the conference, they can be found at https://www.trevena.com/publications.

About OLINVYK® (oliceridine) injection

OLINVYK is a new chemical entity approved by the FDA in August 2020. OLINVYK contains oliceridine, 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.

About Trevena

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: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, TRV045 for diabetic neuropathic pain and epilepsy, and TRV027 for acute respiratory distress syndrome and abnormal blood clotting in COVID-19 patients.

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, commercialization of approved drug products and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “objective,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “ongoing,” or the negative of these terms or 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 commercialization of any approved drug product, 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 the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; 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 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.

For more information, please contact:

Investor Contact:

Dan Ferry
Managing Director
LifeSci Advisors, LLC
daniel@lifesciadvisors.com
(617) 430-7576

PR & Media Contact:

Sasha Bennett
Associate Vice President
Clyde Group
Sasha.Bennett@clydegroup.com
(239) 248-3409

FAQ

What is the significance of Trevena's abstracts at ANESTHESIOLOGY® 2021?

The acceptance of two abstracts at ANESTHESIOLOGY® 2021 underscores the importance of safety data related to OLINVYK and reflects ongoing interest in its clinical profile.

When will the ANESTHESIOLOGY® 2021 conference take place?

The ANESTHESIOLOGY® 2021 conference will be held from October 8 to 12, 2021, in San Diego, California.

What does OLINVYK treat?

OLINVYK is indicated for the management of acute pain in adults requiring an intravenous opioid analgesic when alternative treatments are inadequate.

What key findings will be presented regarding OLINVYK?

Key findings include safety data showing that elevated body mass index does not affect adverse events associated with oliceridine, as well as safety data in patients with renal impairment.