Phase III program initiated forTRV 130 (oliceridin) for treatment of moderate to severe pain- Trevena Inc.

Trevena, Inc. a clinical stage biopharmaceutical company focused on the discovery and development of biased ligands targeting G protein coupled receptors, announced the launch of the oliceridine (TRV 130) Phase III clinical program with the enrollment of patients in the open label Phase III ATHENA-1 study.

This study will evaluate the safety and tolerability of oliceridine in patients with acute moderate-to-severe pain in a variety of clinical settings. ATHENA-1 is a Phase III open label, multicenter study evaluating the safety and tolerability of oliceridine in approximately 900 patients. The study will enroll eligible patients with moderate to severe pain caused by medical conditions or surgery. Patients will be treated with oliceridine on an as-needed basis via IV bolus, patient-controlled analgesia (PCA) administration, or both, as determined by the investigator. The primary objective is to assess the safety and tolerability of oliceridine. Pain intensity will be measured as a secondary endpoint. The Company also announced that an End-of-Phase II meeting with FDA has been scheduled for later this quarter. In the second quarter, the Company expects to communicate additional details of its Phase III development program, including details of its pivotal studies of oliceridine in acute moderate-to-severe pain.

Comment: The intravenous drug, TRV 130, is a mu opioid receptor modulator designed to relieve pain following abdominoplasty, or tummy-tuck surgery. In a Phase IIb study involving 200 patients, the drug easily beat out placebo in reducing patient-reported pain and measured up to standard morphine on the same scale. TRV 130 also attained significantly lower rates of vomiting, nausea and breathing problems compared with morphine, suggesting that Trevena can duplicate the results in Phase III trials scheduled for 2016.