PainReform Announces Positive Safety Profile for PRF-110 in Phase 3 Bunionectomy Study
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) ha annunciato risultati preliminari positivi sulla sicurezza dal suo studio in corso di fase 3 per la bunionectomia su PRF-110, una formulazione proprietaria per il dolore post-chirurgico. Lo studio, che ha completato l'arruolamento con 443 pazienti in otto siti clinici negli Stati Uniti, ha rivelato una bassa incidenza di eventi avversi, con una media di solo uno per soggetto.
PRF-110 è posizionato come un potenziale alternativa non oppioide nel mercato del dolore post-operatorio da 12 miliardi di dollari. Il presidente dell'azienda e CEO ad interim, Ehud Geller, ha espresso ottimismo riguardo al potenziale di PRF-110 di essere un punto di svolta nella gestione del dolore post-chirurgico. La formulazione sfrutta la sicurezza consolidata della ropivacaina e componenti GRAS, supportando il suo promettente profilo di sicurezza.
PainReform (Nasdaq: PRFX) ha anunciado resultados preliminares positivos de seguridad de su estudio en curso de fase 3 de bunionectomía de PRF-110, una formulación propietaria para el dolor postquirúrgico. El estudio, que completó el reclutamiento total con 443 pacientes en ocho sitios clínicos en EE. UU., reveló una baja incidencia de eventos adversos, con un promedio de solo uno por sujeto.
PRF-110 se posiciona como una alternativa no opiácea potencial en el mercado del dolor postoperatorio de 12 mil millones de dólares. El presidente de la empresa y CEO interino, Ehud Geller, expresó optimismo sobre el potencial de PRF-110 para ser un cambio de juego en la gestión del dolor postquirúrgico. La formulación aprovecha la seguridad establecida de la ropivacaína y componentes GRAS, respaldando su prometedor perfil de seguridad.
PainReform (Nasdaq: PRFX)는 PRF-110의 3상 족저 굴곡 수술 연구에서 긍정적인 초기 안전성 결과를 발표했습니다. 이 연구는 미국 내 8개 임상 사이트에서 443명의 환자를 모집 완료하였으며, 부작용 발생률이 낮은 것으로 나타났습니다. 평균적으로 환자당 단 1건의 부작용이 발생했습니다.
PRF-110은 120억 달러 규모의 수술 후 통증 시장에서 잠재적인 비오피오이드 대안으로 자리 잡고 있습니다. 회사의 회장 겸 임시 CEO인 에후드 겔러는 PRF-110이 수술 후 통증 관리에서 혁신적인 역할을 할 것이라는 기대감을 표명했습니다. 이 포뮬레이션은 로피바카인의 입증된 안전성과 GRAS 성분을 활용하여 안전성 프로필을 지지합니다.
PainReform (Nasdaq: PRFX) a annoncé des résultats préliminaires positifs sur la sécurité de son étude en cours de phase 3 sur la bunionectomie de PRF-110, une formulation propriétaire pour la douleur post-chirurgicale. L'étude, qui a complété l'inscription avec 443 patients sur huit sites cliniques aux États-Unis, a révélé une faible incidence d'événements indésirables, avec en moyenne un par sujet.
PRF-110 est positionné comme une alternative non opiacée potentielle sur le marché de la douleur postopératoire de 12 milliards de dollars. Le président de l'entreprise et CEO par intérim, Ehud Geller, a exprimé son optimisme quant au potentiel de PRF-110 pour révolutionner la gestion de la douleur post-chirurgicale. La formulation tire parti de la sécurité éprouvée de la ropivacaïne et des composants GRAS, soutenant ainsi son profil de sécurité prometteur.
PainReform (Nasdaq: PRFX) hat positive frühe Sicherheitsergebnisse aus seiner laufenden Phase-3-Studie zur Bunionektomie von PRF-110, einer proprietären Formulierung zur postoperativen Schmerzbehandlung, bekannt gegeben. Die Studie, die mit 443 Patienten an acht klinischen Standorten in den USA vollständig rekrutiert wurde, zeigte eine geringe Inzidenz von Nebenwirkungen, die im Durchschnitt nur eins pro Proband betrug.
PRF-110 wird als potenzielle nicht-opioide Alternative auf dem 12 Milliarden Dollar schweren Markt für postoperative Schmerzen positioniert. Der Vorstandsvorsitzende und interimistische CEO des Unternehmens, Ehud Geller, äußerte Optimismus über das Potenzial von PRF-110, ein wesentlicher Fortschritt im Management postoperativer Schmerzen zu sein. Die Formulierung nutzt die bereits etablierte Sicherheit von Ropivacain und GRAS-Komponenten, was ihr vielversprechendes Sicherheitsprofil unterstützt.
- Completed full enrollment of 443 patients in Phase 3 bunionectomy study
- Low incidence of adverse events, averaging one per subject
- PRF-110 positioned as a potential non-opioid alternative in $12 billion post-operative pain market
- Leverages established safety of ropivacaine and GRAS components
- None.
Insights
The positive safety profile of PRF-110 in the Phase 3 bunionectomy study is a significant milestone for PainReform. With 443 patients enrolled and a reported low incidence of adverse events (averaging one per subject), this data strengthens the potential of PRF-110 as a non-opioid alternative for post-surgical pain management. The study's design as a randomized, double-blind, placebo-controlled trial adds credibility to these early results.
However, it's important to note that while safety data is promising, efficacy results are yet to be reported. The success of PRF-110 will ultimately depend on its ability to effectively manage pain, not just its safety profile. Investors should remain cautious until full efficacy data is available, as this will be important for market adoption and regulatory approval.
PainReform's focus on the
- Full efficacy data is still pending, which will be critical for market success
- The company's financial position and burn rate need to be evaluated
- Potential competition in the non-opioid pain management space should be assessed
While the news is positive, it's important to maintain a balanced view and wait for complete trial results before making investment decisions.
The post-surgical pain management market is ripe for innovation, especially given the ongoing opioid crisis. PRF-110's potential as a non-opioid alternative could be well-received by healthcare providers and patients alike. Key market considerations include:
- Growing demand for safer pain management options
- Potential for PRF-110 to capture market share from opioids
- Possible expansion into other surgical procedures beyond bunionectomy
However, market adoption will depend on full efficacy data, pricing strategy and the ability to differentiate from existing non-opioid alternatives. The
TEL AVIV, Israel, Aug. 20, 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 encouraging early safety results from its ongoing Phase 3 bunionectomy study of PRF-110, the Company’s proprietary post-surgical pain formulation.
The study, which has now completed full enrollment with a total of 443 patients across eight clinical sites in the United States, is designed as a randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of PRF-110 in patients undergoing bunionectomy, a common outpatient surgical procedure. Initial safety data from the study revealed a low incidence of adverse events, averaging just one per subject.
Ehud Geller, Chairman and interim Chief Executive Officer of PainReform, commented, “We are highly encouraged by the early safety data from our Phase 3 bunionectomy study, which reinforces the potential of PRF-110 to be a game-changer in post-surgical pain management. The outstanding safety profile of PRF-110, which leverages the well-established safety of ropivacaine and GRAS (Generally Recognized As Safe) formulation components, positions it as a promising non-opioid alternative in the post-operative pain market. This milestone marks a significant step forward in our mission to address the
PRF-110’s safety and efficacy are further supported by extensive clinical and preclinical testing, positioning it as a potential leader in the market. The company remains committed to advancing PRF-110 through the final stages of clinical development, with the aim of providing patients and healthcare providers with a novel, non-opioid solution for post-surgical pain management.
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
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