Israel-based clinical-stage speciality pharmaceutical company PainReform has reported positive initial safety data from its ongoing Phase III bunionectomy study of PRF-110, a formulation for post-surgical pain.
The randomised, double-blind, placebo-controlled trial is designed to assess the efficacy and safety of PRF-110 in patients undergoing bunionectomy.
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The study enrolled a total of 443 patients across eight US clinical sites.
Initial safety data from the study indicated a reduced incidence of adverse events, with an average of just one per subject.
With this asset, the company intends to offer a new non-opioid solution for post-surgical pain management.
PRF-110 is based on the local anesthetic ropivacaine and is PainReform’s lead product, targeting the postoperative pain relief market.
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By GlobalDataThis oil-based, viscous, clear solution is deposited into the surgical wound bed directly before closure.
PainReform’s drug-delivery system offers an extended period of post-surgical pain relief, without repeated dose administration, to potentially reduce the need for opiates.
PainReform chairman and interim CEO Ehud Geller said: “We are highly encouraged by the early safety data from our Phase III bunionectomy study, which reinforces the potential of PRF-110 to be a game-changer in post-surgical pain management.
“The outstanding safety profile of PRF-110, which leverages the well-established safety of ropivacaine and generally recognised as safe (GRAS) formulation components, positions it as a promising non-opioid alternative in the post-operative pain market. This milestone marks a significant step forward in our mission to address the $12bn post-operative pain market with a safer and more effective therapeutic option.”
