JERUSALEM - Israeli pharmaceuticals company PainReform has received approval from the US Food and Drug Administration (FDA) to begin late-stage clinical studies for a pain relief drug that is a departure from opiate-based narcotics, it said on Tuesday.
Many patients today dealing with pain after surgery are prescribed opioids, which can be highly addictive and are at the heart of a costly health crisis in the United States.
PainReform said the FDA had given it a green light to carry out two Phase 3 trials on its product PRF-110, which prolongs the action of a local analgesic, or painkiller, called ropivacaine. The studies will focus on post-operative pain relief in soft and hard tissue.
The drug is administered during surgery, before the wound is sutured. An earlier study showed PRF-110 was able to relieve pain for up to 72 hours - 10 times longer than the current standard of care, PainReform said.
This is a crucial period when pain is maximal and opioids are often given, said Chief Executive Eli Hazum.
"This kind of drug can help delay or prevent the prescription of opiates," he told Reuters.
PainReform estimates the market potential for such treatment at $5 billion.
FDA Commissioner Scott Gottlieb said in a statement on Monday the agency "remains focused on striking the right balance between reducing the rate of new addiction by decreasing exposure to opioids and rationalizing prescribing, while still enabling appropriate access to those patients who have legitimate medical need for these medicines."
Opioids were involved in more than 42,000 deaths in the United States in 2016, more than any previous year on record, according to the Centers for Disease Control and Prevention.
There are prescription versions of opioids, like oxycodone, and illegal ones, like heroin. About 40 percent of the opioid overdose deaths involved prescription drugs.
Should PainReform's treatment pass its trials, results for which Hazum estimated could come within a year after they start, it would compete with other non-opiate drugs like Heron Therapeutics' HTX-011, which just finished Phase 3 studies.
"This market will not depend on a single drug," Hazum said.
The company has raised $12 million and is looking for an additional $15 million before beginning the trials, which focus on bunion and hernia operations.
It would consider an initial public offering in New York after the trials are finished, or even at the time of interim results, which could be after about six months, Hazum said.