– Podium presentations of Phase 2 data at 2016 American Society of Anesthesiologists meeting highlighted potential of Breakthrough Therapy-designated oliceridine for the management of moderate-to-severe acute pain –
– Company hosted webcast for investors featuring leading clinicians discussing the unmet needs in injectable pain management and potential benefits of oliceridine –
Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company dedicated to developing innovative new medicines for serious unmet medical needs, today announced highlights from recent presentations, including at the 2016 Annual Meeting of the American Society of Anesthesiologists (ASA) held in Chicago from October 22 to 26, 2016. The company also sponsored a continuing medical education (CME) symposium on emerging therapies in pain management at the ASA meeting.
“We’re pleased to have had the opportunity at the ASA meeting to share our phase 2 clinical data in moderate to severe acute pain patients,” said David Soergel, M.D., Trevena’s chief medical officer. “As outlined in the podium presentations, oliceridine may become a valuable alternative to conventional IV opioids in the hospital.”
Two oral podium presentations reviewed results from Phase 2 studies of oliceridine, including comparisons of oliceridine to morphine. Dr. Jianguo Cheng, M.D., Ph.D, Professor of Anesthesiology at Case Western Reserve University presented data from Trevena’s Phase 2b abdominoplasty study, including analyses of dosing interruptions showing a favorable profile of oliceridine compared to morphine when both drugs were administered by patient-controlled analgesia. Dr. Eugene R. Viscusi, M.D., Professor of Anesthesiology at the Sidney Kimmel Medical College at Thomas Jefferson University presented data from Trevena’s Phase 2 bunionectomy study, including observation of faster onset of pain relief with oliceridine than with morphine. Data from the two presentations complement previously presented Phase 2b data showing that oliceridine reduced pain to a similar extent as morphine, but with fewer adverse events including nausea, vomiting, and respiratory events.
The company also was pleased to sponsor an accredited CME symposium entitled “Gaining Insight into Emerging Pain Management Therapies in an Acute Setting.”
On October 24, 2016, the company hosted an investor event that featured presentations and a panel discussion with three medical experts representing key stakeholders in hospital acute pain management:
• Timothy Beard, M.D., FACS, Chair of Department of Surgery, Bend Memorial Clinic, Oregon; and
• Keith Candiotti, M.D., Professor of Anesthesiology and Internal Medicine, University of Miami School of Medicine, Florida;
• Eric Lavonas, M.D., FACEP, Professor of Emergency Medicine, University of Colorado School of Medicine, Colorado.
Discussion focused on the current state of unmet need with injectable analgesics, including the continued necessity of intravenous opioids to manage pain in the hospital despite the complexity, costs, and adverse outcomes associated with opioid-related adverse events. Speakers also discussed oliceridine’s novel mechanism of action and its potential benefits based on the data collected to date.
To replay the audio webcast of the event, please visit the “Investors” section of the company’s website at www.trevena.com. The webcast will be available until November 24, 2016.
Conventional opioids like morphine are the foundation of treatment of moderate-to-severe acute pain. However, the poor tolerability of these medicines, frequently in the form of nausea and vomiting, complicates pain management and hospital throughput. In addition, potentially fatal opioid-induced respiratory depression remains a critical challenge for patient safety.
Oliceridine, Trevena’s lead product candidate, is a next generation IV analgesic in Phase 3 development for the management of moderate to severe acute pain and has been granted Breakthrough Therapy designation by the U.S. Food & Drug Administration. Oliceridine was specifically designed to improve conventional opioid pharmacology to deliver the pain-reducing potential of an opioid but with fewer associated adverse effects. In a Phase 2b clinical trial, oliceridine provided rapid and powerful analgesic efficacy while demonstrating a wider therapeutic window compared to morphine, suggesting it may be highly effective and well-tolerated for patients in need of strong analgesia. Oliceridine is an investigational product and has not been approved by the FDA or EMA.
Trevena, Inc. is a biopharmaceutical company developing innovative therapies based on breakthrough science to benefit patients and healthcare providers confronting serious medical needs. The company has discovered novel and differentiated drug candidates including oliceridine (TRV130), an FDA-designated Breakthrough Therapy currently in Phase 3 development for intravenous treatment of moderate-to-severe acute pain. Trevena also has discovered TRV734, through Phase 1 clinical trials for oral treatment of moderate-to-severe pain, and TRV250, in preclinical development for the treatment of migraine. The company also has an early stage portfolio of drug discovery programs.
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 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; the uncertainties inherent in conducting clinical trials, including whether oliceridine could be a valuable alternative to conventional opioids; whether interim results from a clinical trial will be predictive of the final results of the trial or results of early clinical trials will be indicative of the results of future trials; expectations for regulatory approvals, including for oliceridine; availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; uncertainties related to the Company’s intellectual property; 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.
Jonathan Violin, Ph.D.
Sr. Director of investor relations
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