KING OF PRUSSIA, PA, USA I January 19, 2016 I Trevena, Inc. (NASDAQ:TRVN), a clinical stage biopharmaceutical company focused on the discovery and development of biased ligands targeting G protein coupled receptors, today announced the launch of the oliceridine (TRV130) Phase 3 clinical program with the enrollment of patients in the open label Phase 3 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 3 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 2 meeting with FDA has been scheduled for later this quarter. In the second quarter, the Company expects to communicate additional details of its Phase 3 development program, including details of its pivotal studies of oliceridine in acute moderate-to-severe pain.
“We are pleased to announce the start of our Phase 3 program with the initiation of ATHENA-1, which will provide data on the safety profile of oliceridine in a wide range of settings,” said Maxine Gowen, Ph.D., chief executive officer. “We also look forward to discussing the oliceridine Phase 3 program with the FDA later this quarter, and remain on track to file an NDA for oliceridine in the second half of 2017.”
About Trevena
Trevena, Inc. is a clinical stage biopharmaceutical company that discovers, develops and intends to commercialize therapeutics that use a novel approach to target G protein coupled receptors, or GPCRs. Using its proprietary product platform, Trevena has identified four biased ligand product candidates – TRV027 to treat acute heart failure (Phase 2b), oliceridine (TRV130) to treat moderate to severe acute pain intravenously (Phase 3), TRV734 to treat moderate to severe acute and chronic pain orally (Phase 1), and TRV250 for acute migraine and other CNS disorders (preclinical).
SOURCE: Trevena
Post Views: 121
KING OF PRUSSIA, PA, USA I January 19, 2016 I Trevena, Inc. (NASDAQ:TRVN), a clinical stage biopharmaceutical company focused on the discovery and development of biased ligands targeting G protein coupled receptors, today announced the launch of the oliceridine (TRV130) Phase 3 clinical program with the enrollment of patients in the open label Phase 3 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 3 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 2 meeting with FDA has been scheduled for later this quarter. In the second quarter, the Company expects to communicate additional details of its Phase 3 development program, including details of its pivotal studies of oliceridine in acute moderate-to-severe pain.
“We are pleased to announce the start of our Phase 3 program with the initiation of ATHENA-1, which will provide data on the safety profile of oliceridine in a wide range of settings,” said Maxine Gowen, Ph.D., chief executive officer. “We also look forward to discussing the oliceridine Phase 3 program with the FDA later this quarter, and remain on track to file an NDA for oliceridine in the second half of 2017.”
About Trevena
Trevena, Inc. is a clinical stage biopharmaceutical company that discovers, develops and intends to commercialize therapeutics that use a novel approach to target G protein coupled receptors, or GPCRs. Using its proprietary product platform, Trevena has identified four biased ligand product candidates – TRV027 to treat acute heart failure (Phase 2b), oliceridine (TRV130) to treat moderate to severe acute pain intravenously (Phase 3), TRV734 to treat moderate to severe acute and chronic pain orally (Phase 1), and TRV250 for acute migraine and other CNS disorders (preclinical).
SOURCE: Trevena
Post Views: 121
