Trevena Announces Presentations During the 36th Annual Scientific Meeting of the American Pain Society
– Results presented from the successful APOLLO-1 Phase 3 pivotal efficacy study of OLINVOTM (oliceridine injection) in moderate-to-severe acute pain –
– New preclinical research highlights the potential for the OLINVO mechanism of action to avoid opioid-induced hyperalgesia –
– Two oral presentations at the APS partner Spring Pain 2017 conference discuss original OLINVO preclinical and clinical research –
KING OF PRUSSIA, Pa., May 17, 2017 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN) today announced multiple data presentations during the 36th Annual Scientific Meeting of the American Pain Society (APS) being held at the David L. Lawrence Convention Center in Pittsburgh, Pennsylvania, May 17 - 20. The presentations highlight preclinical and clinical data for OLINVOTM (oliceridine injection), Trevena’s Breakthrough Therapy-designated investigational product for the management of moderate-to-severe acute pain, and include recently-released results from the successful Phase 3 APOLLO-1 pivotal efficacy study in postsurgical pain. The presentations also feature results from new preclinical studies of OLINVO’s novel mechanism of action at the µ-opioid receptor suggesting that OLINVO and molecules like it may avoid triggering opioid-induced hyperalgesia which, research has shown, may prolong and exacerbate pain in patients treated with conventional opioids.
“OLINVO was designed to improve opioid pharmacology by harnessing groundbreaking discoveries in how opioid receptors work,” said Neil Singla, M.D., chief scientific officer at Lotus Clinical Research and the coordinating investigator for the APOLLO trials. “The basic research, preclinical development, and clinical trials have all consistently shown that OLINVO may provide pain relief comparable to that of conventional opioids with the potential for reduced frequency of costly and dangerous opioid-related gastrointestinal and respiratory adverse effects. New data suggesting the OLINVO mechanism also may avoid or even reverse opioid-induced hyperalgesia is yet another exciting indication that OLINVO may be a valuable new option for patients who require IV opioids but are at risk for poor outcomes caused by opioid-related adverse effects.”
Oral presentations: Tuesday, May 16th, 3:30 - 4:30 p.m. EDT
Michael Lark, Ph.D., chief scientific officer of Trevena, and David Soergel, M.D., chief medical officer of Trevena, presented preclinical and clinical data, respectively, from the OLINVO program as part of a panel entitled “Biased ligands: Is basic science finally starting to pay off?” at the Spring Pain 2017 research conference running in partnership with APS. Their presentations highlighted the basic science and potential advantages of biased ligands as a new class of analgesics.
Poster presentations:
Title: APOLLO-1: randomized, placebo- and active-controlled phase 3 study investigating oliceridine (TRV130), a novel μ receptor G protein Pathway Selective (μ-GPS) modulator, for management of moderate to severe acute pain following bunionectomy
Poster Number: 223
Poster Session: Thursday, May 18, 9:30 - 11:00 a.m. EDT
Title: Assessment of Nociceptive Sensitization with TRV0109101, a Novel µ Receptor G Protein Pathway Selective Modulator (µ-GPS), versus Fentanyl, Morphine, and Oxycodone
Poster Number: 224
Poster Session: Thursday, May 18, 3:45 - 5:15 p.m. EDT
About OLINVOTM (oliceridine injection)
OLINVOTM (oliceridine injection) was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA). OLINVO was specifically designed to improve conventional opioid pharmacology to deliver the pain-reducing potential of an opioid but with fewer associated adverse effects. In Phase 2 and Phase 3 clinical trials to date, OLINVO provided rapid and powerful analgesic efficacy while demonstrating a wider therapeutic window compared with morphine, suggesting it may be highly effective and well-tolerated for patients in need of strong analgesia. OLINVO is an investigational product and has not been approved by the FDA or any other regulatory agency. If approved, the Company expects OLINVO to be a Schedule II controlled substance.
About moderate-to-severe acute pain management in hospitals
Pain management is essential for patient recovery and discharge from hospitals and ambulatory surgery centers. Despite the use of other approaches to pain relief, IV opioids often remain necessary for treating moderate-to-severe pain: approximately 50 million hospital patients in the U.S. are treated each year with conventional IV opioids. However these medications are associated with important adverse effects: nausea and vomiting occur in approximately 30% of postoperative patients and contribute approximately $1 billion in U.S. hospital costs; opioid-induced respiratory depression can threaten patient safety and accounts for up to $28,000 in additional hospital costs per patient. This unmet need is highest for patients whose pain management requires an IV opioid but are at risk from opioid-induced respiratory depression, may suffer surgical complications from post-operative vomiting, or whose recovery may be prolonged by post-operative nausea and vomiting.
About Trevena
Trevena, Inc. is a biopharmaceutical company developing innovative therapies based on breakthrough science to benefit patients and healthcare providers confronting serious medical conditions. The Company has discovered four novel and differentiated drug candidates, including OLINVO. Trevena also has discovered TRV250, in early clinical development for the treatment of migraine, and TRV734 for pain. The Company maintains an early stage portfolio of drug discovery programs.
Cautionary note on 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 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 preclinical and clinical trials, including the interpretation of the top-line results from the APOLLO trials, whether OLINVO may avoid triggering or reverse opioid-induced hyperalgesia, whether OLINVO may provide pain relief comparable to conventional opioids with the potential for reduced frequency of costly and dangerous opioid-related gastrointestinal and respiratory adverse effects, and whether OLINVO may be a valuable new option for patients who require IV opioids but are at risk for poor outcomes caused by opioid-related adverse effects; the uncertainties inherent in conducting clinical trials; expectations for regulatory approvals; 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.
Contacts Investors: Jonathan Violin, Ph.D. Vice President, Corporate Strategy & Investor Relations 610-354-8840 x231 jviolin@trevena.com Media: Public Relations PR@trevena.com
Released May 17, 2017