PainReform Ltd. is a pharmaceutical company, which focuses on reformulation of established therapeutics. It offers PRF-110, an oil-based, viscous, clear solution that is deposited directly into the surgical wound bed prior to closure to provide localized and extended post-operative analgesia. The company was founded by Lihu Avitov and Dan Teleman in 2007 and is headquartered in Herzliya, Israel.
相关临床试验
4
0 进行中
药物批准
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监管机构
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监管机构数
成立时间
2007
已完成
2
50.0%
招募中
1
25.0%
Unknown
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25.0%
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- PainReform has launched its development plan for OcuRing-K, a bioerodible sustained-release implant that delivers ketorolac directly into the eye during cataract surgery to prevent post-operative pain and inflammation. - The technology addresses major limitations of traditional eye drop regimens by providing consistent therapeutic levels with significantly lower total drug exposure than standard treatments. - Preclinical studies and Phase I clinical evaluation demonstrated reductions in post-surgical pain and inflammation while using markedly lower drug exposure compared to conventional eye-drop regimens. - The company is advancing toward Phase 2 clinical trials in the US, targeting a market with approximately 4.5 million cataract surgeries performed annually and over $9 billion in global procedure volume.
- PainReform Ltd. announced a strategic $3 million investment in LayerBio Inc. to expand its non-opioid pain management pipeline into ophthalmology, targeting the 3 million annual U.S. cataract surgeries. - The investment centers on LayerBio's OcuRing-K, a sustained-release intraocular ring that delivers 30 days of anti-inflammatory and analgesic therapy following cataract procedures, eliminating the need for traditional eye drops. - Under the milestone-based agreement, PainReform will receive majority equity and board control of LayerBio, with an initial $600,000 investment followed by additional tranches tied to clinical development milestones. - The partnership leverages LayerBio CEO Dr. Ken Mandell's expertise as a Harvard-trained ophthalmologist and co-inventor of FDA-approved ocular therapies, reducing execution risk for the Phase II clinical trial.
• PainReform's Phase 3 clinical trial of PRF-110 for post-surgical pain management in bunionectomy patients did not meet its primary endpoint. • The trial demonstrated statistically significant pain reduction over placebo in the first 48 hours post-surgery, but data from the final 24 hours was unclear. • The company has initiated R&D activities to refine PRF-110's pharmacokinetics and pharmacodynamics based on the study data. • PainReform is reviewing strategic options, including using in-vitro models to address the 72-hour requirement issue before further clinical work.
• PainReform's PRF-110 demonstrated statistically significant superiority over placebo in reducing pain within the first 48 hours post-bunionectomy, according to initial Phase 3 data. • The extended-release formulation of ropivacaine aims to provide prolonged pain relief and reduce the need for opioids in post-surgical settings, enhancing patient recovery. • Data for the subsequent 24-hour period is currently under review due to incoherence, with PainReform collaborating with Lotus Clinical Research to resolve the issue. • The Phase 3 trial is a randomized, double-blind, placebo- and active-controlled study evaluating PRF-110's analgesic efficacy and safety following bunionectomy.
• PainReform's PRF-110 demonstrated statistically significant pain reduction compared to placebo in the first 48 hours post-bunionectomy, suggesting effective early postoperative pain relief. • Data from the subsequent 24-hour period, crucial for the trial's primary endpoint, is currently under review due to inconsistencies, impacting the comprehensive efficacy assessment. • PRF-110, an extended-release formulation of ropivacaine, aims to provide prolonged analgesia and reduce opioid use in post-surgical pain management. • The Phase 3 trial is ongoing, with PainReform collaborating with its CRO to resolve data issues and provide further updates on PRF-110's overall efficacy.
- PainReform's PRF-110, a non-opioid post-surgical pain relief solution, demonstrates compatibility with both non-absorbable and resorbable sutures in human clinical trials. - In vitro studies showed PRF-110 did not impact the mechanical properties of PROLENE™ and Vicryl™ sutures after 14 days, compared to controls. - These findings support the safety and efficacy of PRF-110 for extended post-surgical pain relief without compromising suture integrity. - PRF-110 is an oil-based, viscous solution of ropivacaine designed for direct application into the surgical wound bed.
