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.
Company Overview
PainReform Ltd is a clinical-stage specialty pharmaceutical company dedicated to the reformulation of established pain therapeutics. With a focus on innovation within the postoperative analgesia and extended-release drug-delivery space, the company is committed to transforming pain management for both physicians and patients. By leveraging the FDA 505(b)(2) regulatory pathway, PainReform aims to enhance the clinical efficacy of existing medications while reducing adverse effects and optimizing dosing convenience.
Core Technologies and Therapeutic Advances
PainReform’s portfolio is anchored by its lead product candidate, PRF-110, which is based on the local anesthetic ropivacaine. Utilizing a proprietary, oil-based, viscous solution, PRF-110 is deposited directly into the surgical wound bed prior to closure. This innovative approach ensures localized, extended postoperative analgesia by maintaining therapeutic drug concentrations at the site of tissue injury over an extended period. The formulation addresses common limitations of traditional pain management therapies by reducing the necessity for repeated dosing and potentially lowering reliance on opioids.
Operational Strategy and Market Position
The company operates within the niche of drug reformulation, addressing specific clinical needs within the pain management segment. Through its disciplined focus on reformulating proven therapeutics, PainReform differentiates itself by applying unique technologies that enhance drug performance and patient compliance. The company’s operational model blends ongoing clinical research with strategic process improvements designed to bolster future commercialization efforts, thereby ensuring a resilient market presence in a dynamic therapeutic landscape.
Competitive Landscape and Differentiating Factors
PainReform competes in a complex landscape where innovation in drug delivery systems is critical to success. Unlike companies that develop entirely new molecular entities, PainReform capitalizes on reformulating established therapies to improve their safety and efficacy profiles. This approach allows the company to navigate regulatory pathways more efficiently while providing significant clinical benefits. Its extended-release technology is a key differentiator, offering both a therapeutic and operational advantage in a competitive market characterized by high standards of care and rigorous regulatory oversight.
Product Focus and Clinical Advantages
At the heart of PainReform’s clinical efforts is PRF-110, a product designed to address the unmet need for sustained postoperative pain relief. The product's oil-based, clear solution enables a streamlined mode of application and controlled drug release, tailoring pain management to the procedural landscape. By depositing the medication directly into the surgical wound bed, the company’s strategy minimizes the potential for systemic side effects and improves the overall patient experience. This method supports a growing clinical consensus that targeted, extended-release formulations can substantially improve postoperative recovery trajectories.
Industry Insights and Technological Integration
Within the specialty pharmaceutical sector, the intersection of drug reformulation and advanced delivery platforms represents a significant area of innovation. PainReform’s approach reflects a broader industry trend that prioritizes patient-centric therapies designed to deliver tangible clinical improvements. The integration of advanced drug-delivery systems not only refines the pharmacokinetic profile of established agents but also reinforces the company’s commitment to clinical excellence and operational efficiency. By adhering to rigorous regulatory standards and leveraging industry expertise, PainReform continues to evolve its technology platform, setting benchmarks in extended-release formulations and targeted therapeutic interventions.
Commitment to Quality and Clinical Validation
PainReform’s development strategy is reinforced by a commitment to clinical validation and quality assurance. Robust compatibility studies and ongoing clinical trials underscore the safety and efficacy of its formulations, positioning the company as a trusted entity within the pharmaceutical research community. Each phase of development is guided by stringent quality controls and backed by scientific data, ensuring that the therapeutic benefits of its products are communicated clearly to healthcare professionals and regulatory bodies alike.
Summary
In summary, PainReform Ltd stands as a specialist in the reformulation of pain therapeutics, harnessing innovative extended-release drug-delivery systems to address postoperative pain. Its focused approach, centered around PRF-110 and similar candidates, positions the company favorably within a competitive and evolving market. With an emphasis on clinical benefits, operational efficiency, and regulatory compliance, PainReform continues to advance a portfolio that is both strategic and clinically transformative, ensuring that it meets the essential needs of modern pain management.
PainReform Ltd. (Nasdaq: PRFX), a clinical-stage specialty pharmaceutical company, will have CEO Ilan Hadar present at the Sequire Investor Summit from April 24-26, 2023, in San Juan, Puerto Rico. Hadar's presentation is scheduled for April 26th at 1:30 PM ET. The summit will feature over 40 presentations from public companies, with opportunities for attendees to engage in one-on-one meetings and networking events. PainReform is focused on reformulating established therapeutics, with PRF-110 as its lead product targeting post-operative pain relief. This product is currently in Phase III clinical trials and utilizes a proprietary drug-delivery system designed for extended pain relief. For more information about the summit, visit puertorico.srax.com.
PainReform Ltd. (Nasdaq: PRFX) has completed the first part of its Phase 3 clinical trial for PRF-110, enrolling 15 patients undergoing unilateral bunionectomy. This trial aims to evaluate the analgesic efficacy and safety of PRF-110, which is applied directly into the surgical site for extended pain relief. The initial phase provided training for surgeons on optimal application methods, and results on pharmacokinetics will be available in May 2023. The second phase will involve approximately 400 patients across seven sites, comparing PRF-110 with ropivacaine and placebo.
PainReform Ltd. (Nasdaq: PRFX) provided a business update for 2022, marking significant advancements in the clinical development of PRF-110, its lead drug candidate targeting post-operative pain relief. The initiation of a Phase 3 clinical trial for bunionectomy has commenced, focusing on a safety pharmacokinetic study with 15 patients in Texas, with results expected in May 2023. Following this, a larger trial involving 400 patients will evaluate pain reduction over 72 hours. Financially, the company recorded a net loss of approximately $8.8 million and has approximately $10.2 million in cash as of December 31, 2022.
PainReform Ltd. (Nasdaq: PRFX) has initiated a Phase 3 clinical trial for its lead drug candidate, PRF-110, targeting post-operative pain relief following bunionectomy. The trial comprises two parts: an open-label safety study with 15 patients, followed by a double-blind study with around 400 patients across multiple sites. PRF-110 aims to provide localized, extended analgesia without the need for repeated dosing, addressing the opioid crisis. Initial pharmacokinetic data is expected in May 2023, with potential to capture a share in the $12 billion post-operative pain market if successful.
PainReform Ltd. (Nasdaq: PRFX) announced on February 7, 2023, that it has received a 180-day extension from Nasdaq to regain compliance with the minimum $1 bid price per share requirement, giving it until August 7, 2023. The company previously failed to maintain this bid price for 30 consecutive trading days, first notified on August 10, 2022. To regain compliance, PRFX must achieve a closing bid price of $1 or higher for 10 consecutive trading days before the deadline. PainReform focuses on reformulating established therapeutics, with its lead product, PRF-110, targeting post-operative pain relief.
PainReform Ltd. (Nasdaq: PRFX) provided a business update for Q3 2022, focusing on PRF-110, a product for post-operative pain relief following bunionectomy surgery. The company made enhancements to its manufacturing process, leading to delays in starting the Phase 3 clinical trial but aims to rectify the issue. As of September 30, 2022, it reported $12.9 million in cash, supporting upcoming milestones. R&D expenses increased to $2.5 million, while net loss rose slightly to $5.6 million. PainReform plans to initiate another Phase 3 trial for pain treatment in hernia repair surgery.
PainReform Ltd. (Nasdaq: PRFX) announced a delay in the Phase 3 trial for PRF-110 due to manufacturing issues, which are expected to enhance efficiency and scalability. CEO Ilan Hadar highlighted optimism based on prior Phase 2 results and the potential of PRF-110 in the $12 billion post-operative pain market as a safer alternative to opioids. The company remains committed to providing updates on the trial's start date as they progress.
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