FDA green lights late-stage testing for Israeli non-opiate technology

An Israeli pharmaceutical company will begin late-stage testing on a non-opiate pain relief with the hope that the technology can easily be adapted into the U.S. market after receiving support from the Food and Drug Administration.

Israeli firm PainReform received FDA approval to start a phase-III clinical trial of an extended-release pain reliever, called PRF-110. The drug is meant to be used for post-surgical incision pain and has been shown to last up to 72 hours — 10 times longer than the current standard of care, the company said in a statement.

Two trials will be conducted in surgery sites of soft and hard tissue — identified as one of the key areas driving the U.S.’s opioid epidemic, where uncontrolled prescriptions of powerful opioid pain relievers have driven overdose deaths and addictions in the country.

“This green light from the FDA enables us to progress towards receiving an NDA (New Drug Approval) for the general use of our breakthrough technology in post-operative extended pain relief,” Dr. Eli Hazum, CEO of PainReform, said in a statement.

PRF-110 is the technology designed by the firm to extend the release of the drug ropivacaine, a numbing agent used before, during and after surgery. PainReform’s technology allows for the continuous and long-acting release of ropivacaine in surgical incisions, the company said.

At least 30 million surgical procedures in the U.S. are considered eligible for PRF-110, the company said.

At least 42,000 people died from opioid overdoses in 2016 and an estimated 2.5 million Americans are addicted to the strong painkillers — both on prescription pills or heroin.