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Trevena Announces Initiation of Oliceridine(TRV130) Phase 3 ATHENA-1 Study, NDA expected H2 2017

Source Link:: http://www.trevenainc.com/news-details.php?id=132

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Additional Information

Management Comment “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.”

http://www.trevenain...

Additional Relevant Details 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.

http://www.trevenain...

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Catalyst Date

Occurred on:

Nov 02, 2017

Occurred Source:

http://www.trevena.com/news-details.php?id=184

Related Projects

Expectations for Trevena's (TRVN) Intravenous Oliceridine in Moderate-to-Severe Acute Pain Ahead of Pivotal Phase III Trial Initiating in Q2 2016 TRVN Executed On: Mar 04, 2016 at 03:30 PM EST

Related Keywords Open-label, Phase 3, Athena-1, Trv130, Iv Bolus, Patient-controlled Analgesia, Pca