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EPOCH 2 Phase III study of HTX 011 in pain control published in Hernia journal

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Last updated:27th Aug 2019
Published:21st Aug 2019
Source: Pharmawand

Heron Therapeutics announced that the results from EPOCH 2, a Phase III study of the investigational agent HTX 011 (bupivacaine + meloxicam extended release) in open inguinal hernia repair surgery with mesh, have been published in the journal, Hernia, in an article entitled "HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in herniorrhaphy: results from the phase III EPOCH 2 study." HTX-011 achieved all primary and key secondary endpoints in EPOCH 2, demonstrating statistically significant reductions in both pain intensity and the use of opioid rescue medications following surgery and an increase in the proportion of patients who were opioid-free.

In EPOCH 2, all primary and key secondary endpoints were achieved. HTX-011 provided superior and sustained pain reduction compared to placebo and bupivacaine solution through the critical 72-hour postoperative window, when pain is often most severe. Significant reductions in pain occurred both early (in the first 8 through 24 hours) and were sustained from 24 through 72 hours. In addition to reductions in average pain intensity scores, HTX-011 significantly reduced the proportion of patients experiencing severe pain through 72 hours compared to placebo and bupivacaine solution. Significant reductions in pain were consistent with the significant decrease in total opioid consumption and the significant increase in opioid-free patients receiving HTX-011, both through 72 hours and as compared to placebo and bupivacaine solution. HTX-011 was well tolerated, with a safety profile comparable to placebo and bupivacaine solution.

See: "HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in herniorrhaphy: results from the phase 3 EPOCH 2 study" E. Viscusi et al. Hernia Online: 19 August 2019 DOI https://doi.org/10.1007/s10029-019-02023-6

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