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Heron Therapeutics Announces Positive Results of HTX-011 in Hernia Surgery

June 12, 2019
As part of the HOPE Project, the agent may reduce postoperative opioid prescriptions.

A PPM Brief

Heron Therapeutics (San Diego, CA) announced1 results of a multicenter study involving 93 patients undergoing outpatient inguinal hernia repair surgery who received the company’s investigational agent, HTX-011, along with a regimen of OTC analgesics (acetaminophen and ibuprofen). An extended-release formulation, HTX-011includes the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam and is aimed at helping to manage post-operative pain.

The study marks the initial phase of Heron’s Helping Opioid Prescription Elimination (HOPE) Project, designed to reduce post-operative opioid prescriptions with HTX-011 at the helm of a multimodal treatment regimen. According to a company press release, the average US patient undergoing inguinal hernia repair surgery receives a discharge prescription of 30 opioids.

The average US patient receives 30 opioid prescriptions following a inguinal hernia surgery. (Source: 123RF)

Patients in the outpatient study were discharged 2 to 3 hours following surgery, and those who met criteria were discharged without a prescription for opioids. Results showed that:

  • 95% of patients receiving HTX-011 with the OTC analgesic regimen did not require opioids to manage their postoperative pain through recovery (Day 15).
  • 91% of patients receiving HTX-011 with the OTC analgesic regimen were discharged without an opioid prescription, and none of these patients subsequently requested an opioid for postoperative pain.
  • HTX-011 was well tolerated with no serious adverse events associated with the addition of the OTC analgesic regimen.
  • Patients indicated an overall high satisfaction with the HTX-011-based analgesic regimen.

“Post-operative pain remains a major problem for surgical patients, and there have been few effective and innovative non-opioid advances for patients who want adequate pain relief without relying on opioids,” said Michael Reinhorn, MD, MBA, FACS, president of the Boston Hernia and Pilonidal Center in Wellesley, MA, in the company’s press release. “HTX-011 may be an important tool that will allow healthcare providers to significantly reduce the use of unnecessary postoperative opioids and have a substantial impact on the opioid crisis we are facing in the US.”

FDA granted HTX-011 a Fast Track designation in 2017 and Breakthrough Therapy designation in 2018. Heron submitted an NDA for HTX-011 in October 2018 and received Priority Review designation in December 2018.

Last updated on: June 14, 2019
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Priority Review Designation Granted for Heron’s HTX-011
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