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Heron's Positive Data, And Other News: The Good, Bad And Ugly Of Biopharma


  • Heron reports positive data from its knee replacement trial.
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Heron Reports Positive Results From Mid-Stage Knee Replacement Trial

Heron Therapeutics (NASDAQ:HRTX) announced that its Phase 2b clinical trial Study 209 has provided positive data with regard to HTX-011. The trial involved testing the drug candidate on patients undergoing total knee arthroplasty. The company stated that the HTX-011 met all primary and secondary endpoints of the study. The drug candidate also showed good tolerance and comparable safety profile.

Study 209 is a Phase 2b study and aimed to assess the potential of HTX-011 in primary unilateral total knee arthroplasty. The patients were given a single, needle-free administration of the drug candidate. The subjects showed a superior pain reduction when compared to patients given placebo or bupivacaine solution through 48 and 72 hours. The patients also consume fewer opioids in comparison to control arm. Fewer patients on the drug candidate reported severe pain through 72 hours. Also, more patients on HTX-011 were assessed ready for discharge at 8, 12, and 24 hours, in comparison to patients receiving bupivacaine solution or placebo.

HTX-011 was found to be well-tolerated in Study 209, and its safety profile was comparable to bupivacaine solution and placebo. Alan J. Rechter, M.D., an orthopedic surgeon at Orthopaedic Associates, LLP said,

"Effective pain management is crucial after TKA to permit earlier mobilization, maximize patient satisfaction and facilitate outpatient surgery. Based on my experience in Study 209, the fast and easy needle-free administration of HTX-011 provided patients with effective and improved pain control despite taking fewer opioids."

Study 209 was a randomized, placebo- and active-controlled, double-blind to assess the analgesic efficacy, safety and pharmacokinetics of the drug candidate locally administered into the surgical site. After the dose escalation phase, 232 patients were randomized. 222 patients were given different combinations of (1) HTX-011 400 mg bupivacaine/12 mg meloxicam given through instillation into the surgical site; (2) HTX-011 400 mg bupivacaine/12 mg meloxicam

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Comments (5)

arena13 profile picture
18% improvement vs placebo not encouraging. Serious questions as result of the study. Not good.
the market's reaction speaks for itself
arena13 profile picture
Down almost 1% today. If it were meaningful news it would be up.
FDA approval in sight!
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