PainReform Announces Development and Successful Manufacturing of New Formulations Providing Anti-Inflammatory and Extended Analgesic Effects
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) ha sviluppato e prodotto con successo nuove formule brevettate per la terapia di sollievo dal dolore post-operatorio prolungato, PRF-110. Queste formule combinano ropivacaina, un anestetico locale, con dexametazone, un agente anti-infiammatorio, per migliorare il recupero post-operatorio e la gestione del dolore.
La compagnia ha creato specifici prodotti combinati contenenti 3,6% o 3,0% di ropivacaina e 0,1-0,5% di dexametazone, che hanno mostrato una stabilità promettente negli studi in corso. Questa formulazione unica affronta la sfida della stabilità del prodotto nelle miscele di ropivacaina e steroidi.
Il approccio di PainReform mira a fornire una gestione del dolore superiore combinando gli effetti analgesici della ropivacaina con le proprietà anti-infiammatorie del dexametazone, riducendo potenzialmente la dipendenza dagli oppioidi dopo l'intervento.
PainReform (Nasdaq: PRFX) ha desarrollado y fabricado con éxito nuevas formulaciones patentadas para su terapia extendida de alivio del dolor postoperatorio, PRF-110. Estas formulaciones combinan ropivacaína, un anestésico local, con dexametasona, un agente antiinflamatorio, para mejorar la recuperación postoperatoria y el manejo del dolor.
La empresa ha creado productos combinados específicos que contienen 3.6% o 3.0% de ropivacaína y 0.1-0.5% de dexametasona, los cuales han mostrado una estabilidad prometedora en estudios en curso. Esta formulación única aborda el desafío de la estabilidad del producto en mezclas de ropivacaína y esteroides.
El enfoque de PainReform busca proporcionar un manejo del dolor superior al combinar los efectos analgésicos de la ropivacaína con las propiedades antiinflamatorias de la dexametasona, reduciendo potencialmente la dependencia de opioides postoperatoriamente.
PainReform (Nasdaq: PRFX)는 성공적으로 새로운 특허 조제인 PRF-110으로 수술 후 통증 완화 요법을 개발하고 제조했습니다. 이 조제는 국소 마취제인 로피바카인과 항염증제인 덱사메타손을 결합하여 수술 후 회복과 통증 관리를 개선합니다.
회사는 3.6% 또는 3.0% 로피바카인과 0.1-0.5% 덱사메타손이 포함된 특정 혼합 제품을 생성했으며, 이들은 진행 중인 연구에서 유망한 안정성을 보여주었습니다. 이 독특한 조제는 로피바카인과 스테로이드 혼합물의 제품 안정성 문제를 해결합니다.
PainReform의 접근 방식은 로피바카인의 진통 효과와 덱사메타손의 항염증 특성을 결합하여 수술 후 오피오이드 의존도를 줄이려고 합니다.
PainReform (Nasdaq: PRFX) a développé et fabriqué avec succès de nouvelles formulations brevetées de sa thérapie prolongée de soulagement de la douleur postopératoire, PRF-110. Ces formulations combinent ropivacaïne, un anesthésique local, avec dexaméthasone, un agent anti-inflammatoire, pour améliorer la récupération postopératoire et la gestion de la douleur.
L'entreprise a créé des produits combinés spécifiques contenant 3,6 % ou 3,0 % de ropivacaïne et 0,1-0,5 % de dexaméthasone, qui ont montré une stabilité prometteuse dans des études en cours. Cette formulation unique aborde le défi de la stabilité des produits dans les mélanges de ropivacaïne et de stéroïdes.
L'approche de PainReform vise à fournir une gestion de la douleur supérieure en combinant les effets analgésiques de la ropivacaïne avec les propriétés anti-inflammatoires de la dexaméthasone, réduisant potentiellement la dépendance aux opioïdes après l'opération.
PainReform (Nasdaq: PRFX) hat erfolgreich neue patentierte Formulierungen für seine verlängerte postoperative Schmerztherapie, PRF-110, entwickelt und hergestellt. Diese Formulierungen kombinieren Ropivacain, ein Lokalanästhetikum, mit Dexamethason, einem entzündungshemmenden Mittel, um die postoperative Genesung und Schmerzmanagement zu verbessern.
Das Unternehmen hat spezifische Kombinationsprodukte mit 3,6% oder 3,0% Ropivacain und 0,1-0,5% Dexamethason erstellt, die in laufenden Studien vielversprechende Stabilität gezeigt haben. Diese einzigartige Formulierung geht die Herausforderung der Produktstabilität bei Ropivacain-Steroide-Mischungen an.
Der Ansatz von PainReform zielt darauf ab, ein überlegenes Schmerzmanagement zu bieten, indem die schmerzlindernden Wirkungen von Ropivacain mit den entzündungshemmenden Eigenschaften von Dexamethason kombiniert werden, um die Abhängigkeit von Opioiden nach der Operation möglicherweise zu reduzieren.
- Successful development and manufacturing of new patented formulations for PRF-110
- Combination of ropivacaine and dexamethasone may enhance postoperative recovery and pain management
- Promising stability demonstrated in ongoing studies for the new formulations
- Potential reduction in reliance on opioids post-operatively
- None.
PainReform's successful development of new PRF-110 formulations combining ropivacaine with dexamethasone is a significant advancement in postoperative pain management. This approach addresses two critical aspects: extended analgesia and inflammation reduction. The stability achieved in these formulations is particularly noteworthy, as it's a common challenge in such combinations.
The potential impact on opioid reduction in post-surgical care is crucial, aligning with current healthcare priorities. However, it's important to note that while promising, these formulations are still in the development stage. The company needs to demonstrate clinical efficacy and safety through rigorous trials before any market approval.
Investors should monitor upcoming clinical trial announcements and results, as these will be critical in determining the commercial viability of these new formulations.
PainReform's development of stable ropivacaine-dexamethasone combinations for PRF-110 could significantly impact the postoperative pain management market. This innovation addresses a growing demand for opioid-sparing solutions in surgical recovery.
The market potential is substantial, considering the wide application in various surgical procedures. However, competition from established players and alternative pain management technologies should not be overlooked. The success of PRF-110 will largely depend on its clinical performance and ability to demonstrate superior outcomes compared to existing options.
Investors should consider the lengthy regulatory pathway ahead and potential challenges in market adoption, balanced against the significant unmet need in post-surgical pain management.
New formulations designed to enhance postoperative recovery
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
"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: prfx@crescendo-ir.com
Dr. Ehud Geller
Chairman and interim Chief Executive Officer
PainReform Ltd.
Tel: +972-54-4236711
Email: egeller@medicavp.com
FAQ
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What unique challenge does PainReform's (PRFX) PRF-110 formulation address?
