ropivacaine extended release oily solution (PRF-110) / PainReform - LARVOL DELTA

A Study to Evaluate Analgesic Efficacy and Safety of PRF-110 for Post-surgical Pain (clinicaltrials.gov) - P3 | N=428 | Completed | Sponsor: PainReform LTD | Recruiting ➔ Completed | Trial completion date: Jan 2024 ➔ Aug 2024 | Trial primary completion date: Dec 2023 ➔ Jul 2024

Trial completion • Trial completion date • Trial primary completion date • Pain

PainReform Completes Enrollment in the Second Part of its Phase 3 Bunionectomy Trial for PRF-110 (GlobeNewswire) - "PainReform Ltd...announced a major milestone on the way to registration - the successful completion of patient enrollment in its Phase 3 clinical trial for PRF-110, a novel analgesic drug candidate designed for the treatment of post-operative pain. In total, 428 patients have been enrolled at eight clinical sites across the U.S. As the study pain score is being tracked for 72 hours, the end of enrollment is generally the end of the clinical part of the study....The Company anticipates reporting top-line results from the Phase 3 trial in the second half of 2024, which will further inform the regulatory submission process and potential commercialization plans."

Enrollment closed • P3 data: top line • Pain

PainReform Reports Successful Head-to-Head Comparison of PRF-110 Versus Market Leading Post Surgical Analgesia for Extended Postoperative Pain Relief (GlobeNewswire) - "PainReform Ltd...reported in vitro test results comparing the Company’s lead product, PRF-110, versus the industry leader, as a topical analgesia for postoperative pain relief. The in vitro tests were designed to mimic the spreadability attribute critically required for post-surgical topical applications. PRF-110 demonstrated superior formulation properties with respect to surface-tissue spreading, including a greater ability to spread evenly due to its viscosity (PRF-110 1,500 cP vs. about 10,000 cP for commercial competitor), and superior surface interaction with surgical tissue based on a slide test, which demonstrated sliding of the formulations down inclined, dry and wet surfaces. In phosphate-buffered saline, the sliding of PRF-110 was twice that of the competitor."

Preclinical • Pain

A Phase III Study to Evaluate Analgesic Efficacy and Safety of PRF-110 for Post-surgical Pain (clinicaltrials.gov) - P3 | N=415 | Recruiting | Sponsor: PainReform LTD

New P3 trial • Pain

"$PRFX PainReform Provides Further Update on Manufacturing of PRF-110 https://t.co/qXzDaqk05o" (@stock_titan)

Pain

"$PRFX PainReform Provides PRF-110 Manufacturing Update https://t.co/dO45xydLlJ" (@stock_titan)

Pain

PainReform Announces Appointment of Lotus Clinical Research as CRO for Phase 3 Clinical Trial of PRF-110 (Yahoo Finance) - "PainReform...today announced the appointment of Lotus Clinical Research ('LCR') as its clinical research organization ('CRO') to conduct the Company's upcoming Phase 3 trial of PRF-110 in patients undergoing bunionectomy and hernia repair operations and the entering into an agreement with Lotus covering such trials."

New P3 trial • Pain

A Single-dose Open-Label Study to Assess the Safety and Preliminary Efficacy of PRF 110 in Open Herniorrhaphy Surgery (clinicaltrials.gov) - P2; N=15; Completed; Sponsor: PainReform LTD; Recruiting ➔ Completed; N=30 ➔ 15

Clinical • Enrollment change • Trial completion • Pain