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Trial Shows Surgical Pain Managed Without Opioids

Head in hands

(Photo by Cristian Newman on Unsplash)

15 May 2019. Results from a clinical trial show patients recovered from their hernia surgeries with non-opioid pain medications, and stayed off opioids for 15 days. The topline findings from the study were released by Heron Therapeutics Inc. in San Diego, maker of the experimental pain drug being tested, but the results are not yet published in a peer-reviewed journal.

The company is developing the medication code-named HTX-011 designed for use by surgeons to reduce post-operative pain, and as a substitute for opioid pain relievers that continue to be abused at rates in the U.S. reaching emergency levels, along with heroin and fentanyl sold on the street. Overdose deaths from these drugs this year number more than 130 per day, according to National Institute on Drug Abuse. A report by the National Academies of Sciences, Engineering, and Medicine in July 2017 spells out the full scope of the crisis beyond overdose deaths, with some 2 million Americans age 12 and older addicted to prescription opioid drugs and another 600,000 addicted to heroin.

Heron Therapeutics’ main technology is a process for delivering drugs called Biochronomer used in HTX-011 that delivers a combination of compounds in a single injection. With Biochronomer, drug compounds are encased with biocompatible and degradable polymers that keep the drug compounds separate in the injection. But the polymers also enable their payloads to erode over time, allowing for long-term release of the drugs.

HTX-011 is designed to relieve post-surgical pain. The treatment combines the current local anesthetic bupivacaine with the anti-inflammatory drug meloxicam, delivered together with a needle-free syringe. HTX-011 is given once and allowed to coat affected tissue in the surgical site before suturing.

The late-stage clinical trial tested HTX-011 in patients receiving surgery to repair a hernia, weakness in the abdomen causing pain or protrusions in the groin. Heron says patients on average receive 30 opioid pain relievers following this kind of surgery. In the trial, 93 patients at a Houston, Texas hospital undergoing hernia surgery received HTX-011 before suturing. After surgery, patients were randomly assigned to receive only over-the-counter pain relievers, 300 or 600 milligrams of ibuprofen and 1 gram of acetaminophen. There were no other placebo or comparison groups.

Heron says a similar trial reported in January 2019 shows the vast majority of hernia patients (90%) treated with HTX-011 and given over-the-counter pain drugs did not need opioids in the 72 hours following surgery. In the new study, the hernia patients were tracked for 15 days following surgery, looking for use of opioid drugs for pain relief.

The results released by Heron show nearly all (95%) of the patients treated with HTX-011 and given over-the-counter pain pills did not need opioids to manage their post-surgical pain. Nearly as many patients (91%) did not receive an opioid prescription upon discharge, and none of those participants requested opioids in the days following release. Participants noted high satisfaction with their treatments on a standard medication-response questionnaire, and no adverse effects from the treatments were reported, according to the company.

Heron says HTX-011 has been tested in a number of clinical trials for different types of surgery including bunion removal — see the Science & Enterprise report from March 2018 — knee reconstruction, and breast augmentation, as well as hernia repair. FDA is now reviewing the company’s new drug application, after receiving fast-track and breakthrough designations for HTX-011 from the agency in 2017 and 2018 respectively.

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