Trevena Jumps on Breakthrough Therapy Designation

Health and Healthcare

Published: February 22, 2016 10:05 am

Last Updated: January 13, 2020 12:54 pm

Trevena Inc. (NASDAQ: TRVN) is one of the biopharma companies leading the bulls’ charge to start out this week. This movement is coming from the U.S. Food and Drug Administration (FDA) granting a Breakthrough Therapy designation to the company’s lead product candidate, intravenous oliceridine (TRV130), for the management of moderate-to-severe acute pain.

Following two successful Phase 2 studies, oliceridine is now in Phase 3 development. The Athena-1 safety and tolerability study is ongoing, with pivotal studies expected to begin in the second quarter of 2016.

Oliceridine was designed to optimize μ opioid receptor pharmacology to deliver an improved analgesic profile, and this was previously granted Fast Track designation by the FDA. Also Breakthrough Therapy designation provides all the benefits of the Fast Track program, as well as more intensive FDA guidance on preparing an efficient drug development program and eligibility for rolling review and priority review.

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Trevena CEO Maxine Gowen, Ph.D., commented on the results:

We are delighted that the FDA has chosen to grant Breakthrough Therapy designation to oliceridine. There is an urgent need for a novel analgesic that delivers powerful pain relief with improved safety and tolerability. We believe this designation recognizes our promising Phase 2 study data for oliceridine, which showed encouraging differentiation from morphine. We look forward to working even more closely with the FDA to facilitate our development of oliceridine.

Shares of Trevena were up nearly 18% at $9.50 Monday morning, with a consensus analyst price target of $15.64 and a 52-week trading range of $5.05 to $13.57.

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