JERUSALEM (Reuters) - Israeli pharmaceuticals company PainReform has received approval from the U.S. 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.
FILE PHOTO: A pharmacists holds prescription painkiller Oxycodone Hydrochloride, 30mg pills, made by Mallinckrodt at a local pharmacy, in Provo, Utah, U.S., April 25, 2017. REUTERS/George Frey/File Photo
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.
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