TEL AVIV – PainReform Ltd. (NASDAQ:PRFX), a specialty pharmaceutical company, has announced promising early safety results from its Phase 3 study of PRF-110 in patients undergoing bunionectomy. The study, which has reached full enrollment with 443 patients across eight U.S. clinical sites, is evaluating the efficacy and safety of PRF-110, a non-opioid post-surgical pain relief solution.
Initial data indicates a low incidence of adverse events, with an average of just one per subject. PRF-110 is based on the local anesthetic ropivacaine and is designed to deliver extended postoperative pain relief. The company's Chairman and interim CEO, Ehud Geller, expressed optimism about the formulation's potential as a game-changer in post-surgical pain management.
This development is part of PainReform's mission to address the significant post-operative pain market with a safer and more effective therapeutic option. Geller highlighted the formulation's use of well-established safety components, positioning it as a promising alternative in the market.
The company is advancing PRF-110 through the final stages of clinical development, aiming to offer a novel solution for post-surgical pain management that reduces the potential need for opiates. This news follows extensive clinical and preclinical testing that supports the safety and efficacy of PRF-110.
PainReform specializes in reformulating established therapeutics, with PRF-110 being their lead product targeting the postoperative pain relief market. The extended-release drug-delivery system is designed to provide localized analgesia without the need for repeated dosing.
The information in this article is based on a press release statement from PainReform Ltd.
In other recent news, clinical-stage specialty pharmaceutical company PainReform Ltd. has made significant strides in the development of its postoperative pain relief therapy, PRF-110. The company has successfully developed new patented formulations of PRF-110, designed to enhance recovery after surgery by combining an analgesic and an anti-inflammatory agent. Additionally, PainReform has reported encouraging safety data for PRF-110, with maximum blood levels well within the safe limits set by the FDA.
Furthermore, PainReform has filed a patent for a new manufacturing process for PRF-110. This process is expected to enhance manufacturing efficiency and reduce production costs, a significant development in anticipation of a future market launch. However, the company has also received a notice from Nasdaq regarding its failure to meet the minimum bid price requirement, with a 180-day deadline set to regain compliance.
These are recent developments for PainReform, which continues to focus on addressing the postoperative pain relief market, emphasizing the reduction of opioid need. The company's progress in developing and testing PRF-110, along with its efforts to streamline production and maintain regulatory compliance, represent key aspects of its ongoing operations.
InvestingPro Insights
In light of PainReform Ltd.'s (NASDAQ:PRFX) recent announcement regarding their Phase 3 study of PRF-110, investors may be keen to understand the financial health and market performance of the company. According to InvestingPro data, PainReform holds a market capitalization of 1.08 million USD, which is reflective of the company's current valuation in the market.
The stock performance of PainReform has been challenging, with the price having fallen significantly over the last year, as indicated by the one-year price total return of -93.62%. This trend is also observed in the short term, with a one-month price total return of -38.51%. This performance may raise concerns among investors about the company's current market position and future prospects.
InvestingPro Tips provide further insights into the company's financial situation. PainReform is noted for holding more cash than debt on its balance sheet, which could be a sign of financial stability. However, the company is quickly burning through cash, and its short-term obligations exceed its liquid assets, indicating potential liquidity challenges. Additionally, the company has not been profitable over the last twelve months, which is a critical consideration for investors looking at the company's long-term viability.
For those interested in a more comprehensive analysis, InvestingPro offers additional tips on PainReform Ltd., including insights on valuation, stock performance, and profitability. There are a total of 14 InvestingPro Tips available for PainReform, which can be accessed through their dedicated page on InvestingPro for a deeper dive into the company's financial metrics and market performance.
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