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May 14, 2014
08:06 EDTHRTXHeron selects HTX-011 as lead product for post-surgical pain program
Heron Therapeutics announced that it has selected HTX-011, a unique combination product utilizing its proprietary Biochronomer polymer-based drug delivery platform, as the lead product candidate for its post-surgical pain program. HTX-011 is designed to slowly release the local analgesic agent bupivacaine and the NSAID meloxicam locally at the site of the surgery over 3-5 days. By slowly delivering these agents directly to the location of the pain, lower doses can be used, which should result in greater efficacy with a lower risk of side effects. In a validated animal model, HTX-011 significantly reduced mean pain intensity compared to the current market leader, Exparel for up to 72 hours following surgery. Based on these results, the company has initiated a Phase 1 enabling toxicology study, to be followed by the initiation of a Phase 1 study in the fall.
News For HRTX From The Last 14 Days
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July 24, 2015
08:44 EDTHRTXHeron Therapeutics management to meet with Brean Capital
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July 23, 2015
08:08 EDTHRTXHeron Therapeutics initiates second Phase 2 HTX-011 trial
Heron Therapeutics announced that it has initiated a second Phase 2 clinical trial of HTX-011. HTX-011, which utilizes Heronís proprietary Biochronomer drug delivery technology, is a long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the prevention of post-operative pain. The placebo-controlled, dose-finding, Phase 2 clinical trial in approximately 60 patients undergoing inguinal hernia repair will evaluate the efficacy and safety of HTX-011, containing 200 mg or 400 mg of bupivacaine combined with meloxicam, compared to placebo. HTX-011 is also currently being evaluated in a placebo-controlled, dose-finding, Phase 2 clinical trial in patients undergoing bunionectomy. In a previously completed, placebo-controlled, Phase 1 clinical trial, HTX-011 achieved the desired pharmacokinetic profile for both bupivacaine and meloxicam, with therapeutically relevant plasma bupivacaine levels sustained for 2-3 days.
July 20, 2015
08:03 EDTHRTXHeron resubmits SUSTOL NDA to FDA
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