Heron Announces FDA Submission of HTX-011 NDA for Postoperative Pain Management
Heron Therapeutics, Inc. (HRTX)
Last heron therapeutics, inc. earnings: 3/2 07:30 am
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Source: PR Newswire
SAN DIEGO, Oct. 31, 2018 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-011. HTX-011 is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain. HTX-011 was granted both Breakthrough Therapy and Fast Track designations from the FDA. The NDA filing is based on the results of 7 completed clinical studies in 5 bony and soft tissue surgical procedures that included over 1,000 patients who received HTX-011. These completed clinical studies included two Phase 3 studies in which HTX-011 demonstrated superior, sustained postoperative pain re
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- 4/19/24 - Form PRE
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