PainReform Announces Development and Successful Manufacturing of New Formulations Providing Anti-Inflammatory and Extended Analgesic Effects

TEL AVIV, Israel, Aug. 12, 2024 (GLOBE NEWSWIRE) -- PainReform Ltd. (NASDAQ:PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, announces the successful development and manufacturing of new patented formulations of its extended postoperative pain relief therapy, PRF-110. These novel formulations may incorporate both the analgesic and an anti-inflammatory agent, designed to enhance postoperative recovery.

Nerve blockades are critical for managing pain over extended periods, preventing complications, and accelerating recovery post-surgery. Adding an anti-inflammatory agent, such as a steroid, to a local anesthetic like ropivacaine has been demonstrated to extend and enhance the anesthetic effect. This combination not only provides a quicker onset of pain relief but also reduces the reliance on opioids post-operatively.

Ropivacaine is preferred over bupivacaine for surgical blocks due to its lower neurotoxicity and cardiotoxicity, as well as a reduced risk of bone chondrotoxicity. By combining ropivacaine with dexamethasone, a potent anti-inflammatory agent, PainReform aims to deliver superior pain management. This combination is already employed in various peripheral nerve blocks, including transversus abdominis plane blocks, interscalene blocks, and adductor canal blocks.

PainReform's PRF-110 formulation uniquely supports the administration of ropivacaine-steroid mixtures while ensuring product stability—a challenging feat with such combinations. The company holds a patent for the ropivacaine and dexamethasone mixture and has successfully manufactured specific combination products of PRF-110, containing 3.6% or 3.0% ropivacaine and 0.1-0.5% dexamethasone. These formulations have demonstrated promising stability in ongoing studies.

"Long-acting mixtures of local anesthetics and anti-inflammatory agents are extensively used in nerve blocks, orthopedics, and other medical fields to provide symptomatic relief," said Ehud Geller, Chairman and interim Chief Executive Officer of PainReform. "The unique properties of PRF-110, including its long-acting nature, viscosity, and safety, position it well for combination with anti-inflammatory agents to further enhance outcomes in postoperative pain management and recovery."

PainReform remains committed to advancing its pipeline of innovative pain management therapies to improve patient outcomes and quality of life. The company will continue to update stakeholders on the progress of its clinical studies and product development.

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: [email protected]

Dr. Ehud Geller

Chairman and interim Chief Executive Officer

PainReform Ltd.

Tel: +972-54-4236711

Email: [email protected]