Trevena, Inc. Completes Enrollment of Phase 3 Apollo Pivotal Efficacy Trials of Oliceridine for Moderate To Severe Acute Pain
January 04, 2017 at 05:30 pm IST
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Trevena, Inc. announced that it has completed enrollment of its Phase 3 APOLLO-1 and APOLLO-2 pivotal efficacy studies of oliceridine (TRV130) in moderate-to-severe acute pain following bunionectomy and abdominoplasty. The APOLLO studies were designed based on the Phase 2 clinical trials of oliceridine that were successful in showing potential differentiation of oliceridine from morphine. The company expects top-line results to include measures of efficacy, safety, and tolerability of oliceridine. Both APOLLO trials are Phase 3, multicenter, randomized, double-blind, placebo-and active-controlled studies of oliceridine for the treatment of moderate to severe acute pain. The APOLLO-1 study is evaluating pain for 48 hours following bunionectomy, and the APOLLO-2 study is evaluating pain for 24 hours following abdominoplasty. In each trial, patients were randomized to receive placebo, morphine, or one of three regimens of oliceridine by patient-controlled analgesia (PCA) device for the management of their post-operative pain. Each study enrolled approximately 375 patients, allocated equally across study arms. The primary objective in each study is to evaluate the analgesic efficacy of oliceridine compared to placebo. Secondary endpoints include comparisons of efficacy, safety, and tolerability of oliceridine to morphine. 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 FDA. 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 any other regulatory agency.
Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of medicines for patients with central nervous system (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 Companyâs pipeline includes three differentiated investigational drug candidates: TRV045 for diabetic neuropathic pain and epilepsy, TRV250 for the acute treatment of migraine and TRV734 for maintenance treatment of opioid use disorder. TRV045 is a novel, highly 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. TRV734 is a small molecule G-protein biased ligand of the mu opioid receptor (MOR).
TREVENA, INC. 
