PainReform Announces Favorable Safety Profile of PRF-110, Indicating Potential for Use in New Surgical Applications Requiring Higher Doses

Rhea-AI Summary

PainReform (Nasdaq: PRFX) has announced favorable safety data for its lead product candidate, PRF-110, a post-operative pain management solution. Pharmacokinetic studies in herniorrhaphy and bunionectomy trials revealed maximum blood levels (Cmax) at approximately 10% of the FDA-established safety threshold for local anesthetics. This safety profile suggests PRF-110's potential for use in a broader range of surgical applications, possibly at higher doses.

PRF-110 is a viscous, oil-based solution applied directly to surgical wound beds, providing localized and extended postoperative analgesia. It uses ropivacaine, considered the safest long-acting local anesthetic, which may allow for higher doses and larger volumes compared to other anesthetics. This development could significantly reduce reliance on opioids and improve patient outcomes across various surgical procedures.

Positive

• PRF-110 showed maximum blood levels at only 10% of FDA safety threshold
• Favorable safety profile may allow for use in broader surgical applications
• Potential for higher doses and larger product volumes in various surgeries
• PRF-110 uses ropivacaine, considered the safest long-acting local anesthetic
• Product could reduce reliance on opioids for post-operative pain management

Negative

• None.

Medical Research Analyst

The safety data for PRF-110 is indeed promising. With a Cmax at approximately 10% of the FDA safety threshold, it demonstrates a significant safety margin. This could potentially allow for higher doses and larger volumes in various surgical applications, addressing a broader range of postoperative pain management needs.

The use of ropivacaine as the API is noteworthy. As the safest long-acting local anesthetic, it provides an additional layer of safety. The controlled release formulation, avoiding dose dumping, further enhances its safety profile. This combination of factors positions PRF-110 favorably in the competitive landscape of postoperative pain management solutions.

However, it's important to note that while these PK studies show promising results, larger clinical trials will be necessary to fully establish the safety and efficacy across different surgical applications. The potential for reduced opioid reliance is significant, but real-world evidence will be key to confirming this benefit.

Financial Analyst

This safety data could significantly expand PRF-110's market potential. The ability to use higher doses safely opens up opportunities in larger surgical procedures, potentially increasing the addressable market beyond the initial targets of herniorrhaphy and bunionectomy.

However, investors should consider that PainReform is still a clinical-stage company. While promising, this data doesn't guarantee regulatory approval or commercial success. The company will likely need additional capital to fund further clinical trials and potential commercialization efforts.

The opioid crisis presents a significant market opportunity for non-opioid pain management solutions. If PRF-110 can demonstrate efficacy in reducing opioid use post-surgery, it could capture a substantial market share. However, competition in this space is intense, with established players like Pacira Biosciences (Exparel) and Heron Therapeutics (Zynrelef) already in the market.

TEL AVIV, Israel, Aug. 07, 2024 (GLOBE NEWSWIRE) --  PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today announced compelling safety data for its lead product candidate, PRF-110. This data, derived from pharmacokinetic (PK) studies in both herniorrhaphy and bunionectomy clinical trials, highlights PRF-110's promising safety profile, with maximum blood levels (Cmax) recorded at approximately 10% of the FDA-established safety threshold.

Local anesthetics, such as ropivacaine—the active pharmaceutical ingredient (API) in PRF-110—and bupivacaine, the API in other products like Exparel and Zynrelef, are known for their correlation between Cmax levels and the risk of cardiovascular toxicity and central nervous system (CNS) adverse events. The threshold for these adverse events is typically between 2000-4000 ng/ml (Clinical Drug Investigation, 2013, 33 pp. 109-115). The results from the PRF-110 studies suggest that the product remains well within safe limits, underscoring its potential for broader surgical applications.

PRF-110 is a viscous, oil-based, clear solution designed for direct application into the surgical wound bed before closure, providing localized and extended postoperative analgesia. The formulation ensures controlled release of the API over time, avoiding dose dumping. The use of ropivacaine in PRF-110, regarded as the safest long-acting local anesthetic (Local and Regional Anesthesia, 2010; 3: 11–19), is a significant advantage, offering the potential for higher doses and larger product volumes in various surgical operations compared to other anesthetics.

“The safety data we’ve observed with PRF-110 is highly encouraging and supports our belief in its potential to enhance patient care in surgical settings,” said Ehud Geller, Chairman and interim Chief Executive Officer of PainReform. “With its favorable safety profile and the ability to use higher doses, PRF-110 has the potential to address significant unmet needs in postoperative pain management, well beyond just herniorrhaphy and bunionectomy, thereby reducing reliance on opioids and improving overall patient outcomes across a wide range of surgical procedures.”

About PainReform

PainReform is a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics. PRF-110, the Company's lead product is based on the local anesthetic ropivacaine, targeting the postoperative pain relief market. PRF-110 is an oil-based, viscous, clear solution that is deposited directly into the surgical wound bed prior to closure to provide localized and extended postoperative analgesia. The Company's proprietary extended-release drug-delivery system is designed to provide an extended period of post-surgical pain relief without the need for repeated dose administration while reducing the potential need for the use of opiates. For more information, please visit www.painreform.com.

Notice Regarding Forward-Looking Statements

This press release contains forward-looking statements about our expectations, beliefs and intentions including with respect to objectives, plans and strategies and expected timing of results. Forward-looking statements can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. These forward-looking statements are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of our control. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward- looking statements, including, but not limited to, the following: our ability to continue as a going concern, our history of significant losses, our need to raise additional capital and our ability to obtain additional capital on acceptable terms, or at all; our dependence on the success of our initial product candidate, PRF-110; the outcomes of preclinical studies, clinical trials and other research regarding PRF-110 and future product candidates;  our limited experience managing clinical trials; our ability to retain key personnel and recruit additional employees; our reliance on third parties for the conduct of clinical trials, product manufacturing and development; the impact of competition and new technologies; our ability to comply with regulatory requirements relating to the development and marketing of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights and our ability to operate our business without infringing the intellectual property rights of others; the overall global economic environment; our ability to develop an active trading market for our ordinary shares and whether the market price of our ordinary shares is volatile; and statements as to the impact of the political and security situation in Israel on our business, including due to the current war between Israel and Hamas. More detailed information about the risks and uncertainties affecting us is contained under the heading "Risk Factors" included in the Company's most recent Annual Report on Form 20-F and in other filings that we have made and may make with the Securities and Exchange Commission in the future.

Contact: 
Crescendo Communications, LLC
Tel: 212-671-1021
Email: prfx@crescendo-ir.com

Dr. Ehud Geller
Chairman and interim Chief Executive Officer
PainReform Ltd.
Tel: +972-54-4236711
Email: egeller@medicavp.com

FAQ

What is the maximum blood level (Cmax) of PRF-110 compared to FDA safety thresholds?

According to the pharmacokinetic studies, PRF-110's maximum blood levels (Cmax) were recorded at approximately 10% of the FDA-established safety threshold for local anesthetics.

How does PRF-110 (PRFX) differ from other local anesthetics in surgical applications?

PRF-110 is a viscous, oil-based solution applied directly to surgical wound beds, providing localized and extended postoperative analgesia. It uses ropivacaine, considered the safest long-acting local anesthetic, potentially allowing for higher doses and larger volumes compared to other anesthetics.

What potential advantages does PRF-110 (PRFX) offer for post-operative pain management?

PRF-110 offers a favorable safety profile, potential for use in a broader range of surgical applications, possibility of higher doses, and could significantly reduce reliance on opioids for post-operative pain management, improving overall patient outcomes.

In which clinical trials has PainReform (PRFX) tested PRF-110?

PainReform has tested PRF-110 in pharmacokinetic studies during herniorrhaphy and bunionectomy clinical trials, as mentioned in the press release from August 7, 2024.