PainReform Ltd. (NASDAQ:PRFX), a specialty pharmaceutical company, is making progress in its Phase 3 clinical trial for PRF-110, a drug aimed at post-operative pain relief. The company has enrolled over 140 patients in the trial, with a target of up to 400 participants across six U.S. sites. This development puts the company on track to release top-line data by mid-2024.

PRF-110 is PainReform’s lead drug candidate, featuring an extended-release formulation of the local anesthetic ropivacaine. It is designed to be administered directly into the surgical wound bed, potentially reducing the need for systemic opioids post-surgery.

Positive in vitro test results have been reported, demonstrating the drug’s superior formulation properties in terms of tissue spreading when compared to the industry leader.

Financial results for the year ending December 31, 2023, show research and development expenses at approximately $6.0 million, up from $4.4 million the previous year, mainly due to clinical trial and manufacturing costs. General and administrative expenses decreased to about $3.6 million from $4.4 million, primarily due to lower insurance and professional services costs. PainReform reported a net loss of approximately $9.3 million for the year, a slight increase from the $8.8 million loss in the prior year. As of year-end, the company had cash and cash equivalents totaling around $8.0 million.

PainReform’s CEO, Ilan Hadar, expressed confidence in PRF-110’s potential within the $12 billion post-operative pain treatment market. The company cites positive pharmacokinetic data from earlier trial phases and safety and efficacy results from a Phase 2 hernia repair study.

It’s important to note that forward-looking statements involve risks and uncertainties, and the actual results may differ materially from current expectations. Factors such as the need for additional capital and the competitive and regulatory environment can impact PainReform’s future activities and results.