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Trials Show Pain Drug Reduces Post-Surgery Opioid Use

Pills and capsules

(stevepb, Pixabay)

20 March 2018. Initial results from two late-stage clinical trials show an experimental pain drug with non-opioid ingredients reduces the use of opioid pain relievers following surgery, compared to a placebo and standard care. The findings were released yesterday by Heron Therapeutics Inc. in San Diego, maker of the drug code-named HTX-011 tested in the trials.

The company developed HTX-011 to provide an alternative to opioid pain medications, which are increasingly abused, leading to widespread problems of addiction and overdose. A report by the National Academies of Sciences, Engineering, and Medicine in July 2017 spells out the scope of the crisis, with some 2 million Americans age 12 and older addicted to prescription opioid drugs. And National Institute on Drug Abuse, part of National Institutes of Health, cites data showing more than 115 Americans each day die from opioid overdoses.

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 company says the two late-stage trials met all of their primary and secondary objectives. One clinical trial tested HTX-011 with 412 individuals in the U.S. undergoing bunion removal surgery, randomly assigned to receive HTX-011, bupivacaine alone considered the standard care, or a placebo. The results show recipients of HTX-011 experienced 27 and 18 percent less intense pain, compared to the placebo and bupivacaine alone respectively. HTX-011 recipients also took 37 percent fewer opioid pain relievers in the 72 hours following their surgery than placebo recipients, and 25 percent fewer opioids than those receiving bupivacaine. in addition, about 3 in 10 HTX-011 recipients (29%) took no opioids in the 72 hours following their surgery, compared to 2 percent for placebo recipients and 11 percent for bupivacaine alone.

The second clinical trial likewise tested HTX-011 against a placebo and bupivacaine alone, but this time among 418 individuals in the U.S. and Belgium undergoing hernia repair surgery. The findings show participants receiving HTX-011 experienced 23 less intense pain than placebo recipients and 21 percent less pain than those receiving bupivacaine alone. And similar to the bunion surgery trial, HTX-011 recipients took 38 percent fewer opioids in the 72 hours following their procedures than placebo and 25 percent fewer opioids than bupivacaine recipients. Moreover, about half (51%) of HTX-011 recipients took no opioids in the 72 hours following surgery, compared to 22 percent for placebo recipients and 40 percent for those receiving bupivacaine.

Heron says no serious adverse effects or discontinuations related to HTX-011 were reported, while participants receiving the placebo or bupivacaine experienced more adverse effects from opioid drugs than the HTX-011 group. In addition, safety and tolerability profiles for HTX-011 were similar to those for placebo and bupivacaine.

The company plans to submit HTX-011 for review by FDA in the second half of 2018. HTX-011 already has fast-track designation from FDA, and Heron plans to take advantage of a streamlined regulatory pathway allowing for products that use already approved components.

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