Welcome to our dedicated page for Painreform news (Ticker: PRFX), a resource for investors and traders seeking the latest updates and insights on Painreform stock.
PainReform Ltd (PRFX) is a clinical-stage pharmaceutical innovator developing advanced pain management solutions through therapeutic reformulation. This page aggregates official announcements, clinical trial updates, and strategic developments related to the company’s extended-release drug-delivery platform.
Investors and healthcare professionals will find timely updates on PRF-110’s progress through FDA pathways, postoperative analgesia research, and operational milestones. The curated news collection serves as a centralized resource for tracking the company’s unique approach to reducing opioid reliance via localized, sustained pain relief therapies.
Key content categories include clinical trial results, regulatory filings, partnership announcements, and scientific presentations. All materials are sourced from verified channels to ensure accuracy and compliance with financial disclosure standards.
Bookmark this page for streamlined access to PainReform’s latest developments in drug reformulation technology and its evolving position within the specialty pharmaceuticals sector.
PainReform (Nasdaq: PRFX) has announced positive early safety results from its ongoing Phase 3 bunionectomy study of PRF-110, a proprietary post-surgical pain formulation. The study, which has completed full enrollment with 443 patients across eight U.S. clinical sites, revealed a low incidence of adverse events, averaging just one per subject.
PRF-110 is positioned as a potential non-opioid alternative in the $12 billion post-operative pain market. The company's Chairman and interim CEO, Ehud Geller, expressed optimism about PRF-110's potential to be a game-changer in post-surgical pain management. The formulation leverages the established safety of ropivacaine and GRAS components, supporting its promising safety profile.
PainReform (Nasdaq: PRFX) has provided a business update for Q2 2024, highlighting significant progress in the clinical development of PRF-110, their lead drug candidate for post-operative pain relief. Key achievements include:
1. Full enrollment (443 patients) in the second part of Phase 3 clinical trial for bunionectomy
2. Favorable wound healing data from human clinical trials
3. Promising PK study results showing safe limits
4. New patent filed for a highly scalable manufacturing process
5. Development of new formulations combining PRF-110 with anti-inflammatory agents
Financial results show increased R&D expenses of $11.4 million, primarily due to the Phase 3 trial. The company's net loss increased to $12.8 million. As of June 30, 2024, PainReform had $2.8 million in cash and cash equivalents, with an additional $4 million raised in April 2024 through a public offering.
PainReform (Nasdaq: PRFX) has successfully developed and manufactured new patented formulations of its extended postoperative pain relief therapy, PRF-110. These formulations combine ropivacaine, a local anesthetic, with dexamethasone, an anti-inflammatory agent, to enhance postoperative recovery and pain management.
The company has created specific combination products containing 3.6% or 3.0% ropivacaine and 0.1-0.5% dexamethasone, which have shown promising stability in ongoing studies. This unique formulation addresses the challenge of product stability in ropivacaine-steroid mixtures.
PainReform's approach aims to provide superior pain management by combining the analgesic effects of ropivacaine with the anti-inflammatory properties of dexamethasone, potentially reducing reliance on opioids post-operatively.
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.
PainReform (Nasdaq: PRFX) has announced favorable wound healing data from human clinical trials for its lead product, PRF-110. The trials, involving both hard tissue (bunionectomy) and soft tissue (hernia) surgeries, showed that PRF-110 promoted normal wound healing and prevented scar formation. These results build upon previous preclinical studies that demonstrated PRF-110's compatibility with normal wound healing.
Key points:
- PRF-110 contains 55% lecithin, which forms liposome-like structures potentially enhancing wound healing
- No abnormalities in wound healing or scar formation were observed in patients treated with PRF-110
- The company is on track to report top-line results from the Phase 3 trial in the second half of 2024
These findings support PRF-110's potential to provide effective post-surgical pain relief while promoting normal wound healing, potentially enhancing patient outcomes.
PainReform (Nasdaq: PRFX) has announced a significant advancement in the development of its lead asset, PRF-110. The company's new highly scalable manufacturing process has enabled PRF-110 to achieve full product stability for 18 months at room temperature. This milestone is important for ensuring the drug's safety and efficacy, while also simplifying handling, transportation, and reducing associated costs.
The stability study is ongoing and marks a significant achievement for PainReform. The company recently filed a new patent for this manufacturing process, which is expected to significantly bolster future commercialization efforts. PainReform is on track to report top-line results from its Phase 3 trial in the second half of 2024, which will further inform the regulatory submission process and potential commercialization plans.
PainReform (Nasdaq: PRFX) has filed a patent for a new, highly scalable manufacturing process for PRF-110, its flagship post-operative pain control product. This development follows successful completion and testing of the process, marking a significant step towards potential market launch. The improved process includes:
- Continuous Process Manufacturing for increased productivity
- Single Reactor Manufacturing for reduced costs and contamination risk
- Enhanced Batch Size capabilities while maintaining quality
These improvements are expected to reduce production costs and COGS for PRF-110. The company has completed its bunionectomy Phase 3 trial and believes PRF-110 could set a new standard in non-opioid post-operative pain relief.
PainReform has successfully completed patient enrollment for the second part of its Phase 3 clinical trial for PRF-110, a novel analgesic drug candidate aimed at treating post-operative pain. The double-blind, placebo-controlled study enrolled 428 patients across eight U.S. sites. The trial's primary endpoint is to determine the drug's efficacy in reducing post-operative pain intensity over 72 hours compared to a placebo. Secondary endpoints include comparisons with Naropin and assessments of safety and rescue analgesic use. The company anticipates reporting top-line data in the second half of 2024, a critical step towards regulatory submission and potential commercialization.
PainReform, a clinical-stage specialty pharmaceutical company, announced it received a notification from Nasdaq indicating non-compliance with the minimum bid price requirement of $1.00 per share set forth in Listing Rule 5550(a)(2). The company has 180 days, from May 28, 2024, to November 25, 2024, to regain compliance by maintaining a closing bid price of at least $1 for a minimum of ten consecutive business days. Failure to do so may result in delisting, although the company may be eligible for an additional compliance period if it meets other listing standards. The notification does not immediately affect PainReform’s Nasdaq listing or trading under the symbol 'PRFX'.
PainReform provided a business update for Q1 2024, noting significant progress in the clinical development of its lead drug candidate, PRF-110.
The company reached 50% enrollment in the second part of its Phase 3 clinical trial for PRF-110 in bunionectomy, with over 200 patients enrolled across eight U.S. sites. No serious adverse events have been reported.
PainReform expects to announce top-line data in Q3 2024. New studies showed PRF-110's superior in-vitro release rates compared to industry leaders, and the company is optimistic about its potential to reduce opioid use.
Financially, R&D expenses rose to $4.7 million, mainly due to the Phase 3 trial, while general and administrative expenses decreased to $823,000. The company incurred a net loss of $5.5 million. As of March 31, 2024, PainReform held $4.3 million in cash and raised $4 million through a public offering in April 2024.
