PainReform's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by PainReform (PRFX).
Over the past two years, PainReform has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
PRF-110. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
PRF-110 FDA Regulatory Timeline and Events
PRF-110 is a drug developed by PainReform for the following indication: To provide localized and extended post-operative analgesia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PRF-110
- Announced Date:
- June 25, 2026
- Indication:
- To provide localized and extended post-operative analgesia.
Announcement
PRF Technologies Ltd. announced expanded results from its previously reported preclinical study directly comparing its lead product candidate, PRF-110, to ZYNRELEF® (bupivacaine and meloxicam extended-release solution), an approved extended-release product used as a benchmark in the study.
AI Summary
PRF Technologies Ltd. said new preclinical data strengthen its lead pain-relief candidate, PRF-110, in a direct comparison with ZYNRELEF®, an approved extended-release product used as the study benchmark. PRF-110 is a clear, oil-based formulation of ropivacaine designed to be placed in the surgical wound before closure. The goal is to provide long-lasting local pain relief after surgery with one dose and help reduce the need for opioids.
The study used a validated pig model of post-surgery pain and tested both pain relief and drug-release behavior. PRF said the expanded results support PRF-110’s potential and add to the evidence backing the program. The company plans to keep studying the product to better understand its safety, effectiveness, and usefulness across more types of surgeries.
Read Announcement- Drug:
- PRF-110
- Announced Date:
- May 26, 2026
- Indication:
- To provide localized and extended post-operative analgesia.
Announcement
PRF Technologies Ltd. announced positive results from a preclinical study in domestic pigs directly comparing its lead product candidate, PRF-110, to ZYNRELEF® (bupivacaine and meloxicam extended-release solution), an approved extended-release product used as a benchmark in the study.
AI Summary
PRF Technologies Ltd. said its lead pain-relief candidate, PRF-110, showed positive results in a preclinical study in domestic pigs. The study directly compared PRF-110 with ZYNRELEF, an approved extended-release product used as a benchmark. PRF-110 is a ropivacaine-based, oil-based gel designed to be placed in the surgical wound before closure to provide long-lasting pain control after surgery and help reduce opioid use.
In the study, PRF-110 delivered sustained pain relief that was comparable to ZYNRELEF over a 72-hour period after surgery. A key point is that PRF-110 achieved this result with a ropivacaine-only formula, without NSAIDs. PRF said the findings support further development planning and may help guide future study design and regulatory strategy.
Read Announcement- Drug:
- PRF-110
- Announced Date:
- December 27, 2024
- Indication:
- To provide localized and extended post-operative analgesia.
Announcement
PainReform Ltd. nnounced an update regarding its Phase 3 clinical trial evaluating PRF-110 in post-surgical pain management of patients undergoing bunionectomy.
AI Summary
PainReform Ltd. provided an important update on its Phase 3 clinical trial for PRF-110, a treatment aimed at managing post-surgical pain in bunionectomy patients. Initially, the trial showed that PRF-110 significantly reduced pain compared to a placebo during the first 48 hours after surgery. However, further analysis revealed that the data from the final 24-hour period of the study did not meet the primary endpoint, which required clear and consistent results over a full 72 hours. As a result, the trial did not achieve its main goal. The company is now focusing on research and development efforts to better understand the drug’s pharmacokinetics and pharmacodynamics. PainReform plans to use high-level in vitro models to address the issues identified in the last 24-hour period before considering additional clinical trials in the future.
Read Announcement- Drug:
- PRF-110
- Announced Date:
- November 20, 2024
- Indication:
- To provide localized and extended post-operative analgesia.
Announcement
PainReform Ltd. announced the receipt of partial topline data from its contract research organization (CRO), Lotus Clinical Research ("Lotus"), for the Phase 3 clinical trial evaluating PRF-110 in post-surgical pain management of patients undergoing bunionectomy.
AI Summary
PainReform Ltd. recently announced that it has received partial topline data from its contract research organization, Lotus Clinical Research, for a Phase 3 clinical trial. The study is evaluating the effectiveness of its lead product, PRF-110, an extended-release formulation of ropivacaine, in managing post-surgical pain for patients undergoing bunionectomy. Initial analysis of the data showed that PRF-110 provided statistically significant pain reduction compared to a placebo during the first 48 hours after surgery. However, the data for the following 24-hour period, which is critical in assessing the trial’s primary endpoint, has been inconclusive due to inconsistencies. PainReform is working closely with Lotus Clinical Research to resolve these issues and complete the analysis, while maintaining cautious optimism about PRF-110’s potential to improve post-surgical pain management.
Read Announcement- Drug:
- PRF-110
- Announced Date:
- September 11, 2024
- Indication:
- To provide localized and extended post-operative analgesia.
Announcement
PainReform Ltd. announced positive findings regarding the compatibility of sutures in human clinical trials of its lead product, PRF-110. PRF-110 is designed to provide extended, non-opiate, post-surgical pain relief.
AI Summary
PainReform Ltd. recently announced encouraging results from its clinical trials regarding the compatibility of sutures with its lead product, PRF-110. Designed to offer extended, non-opiate post-surgical pain relief, PRF-110 underwent testing to ensure that its oily solution does not affect commonly used surgical sutures.
The Company carried out in vitro studies on both non-absorbable PROLENE™ and resorbable Vicryl™ sutures. These tests measured the mechanical properties, including the breaking force and elongation, at the start of the study and after 14 days. The results showed that PRF-110 does not impact the sutures' performance, confirming that it can be safely used during wound closures after surgery. This positive finding supports the safety and efficacy of PRF-110 as a promising option for providing prolonged pain relief without compromising suture integrity.
Read Announcement
PainReform FDA Events - Frequently Asked Questions
As of now, PainReform (PRFX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, PainReform (PRFX) has reported FDA regulatory activity for PRF-110.
The most recent FDA-related event for PainReform occurred on June 25, 2026, involving PRF-110. The update was categorized as "Results," with the company reporting: "PRF Technologies Ltd. announced expanded results from its previously reported preclinical study directly comparing its lead product candidate, PRF-110, to ZYNRELEF® (bupivacaine and meloxicam extended-release solution), an approved extended-release product used as a benchmark in the study."
Currently, PainReform has one therapy (PRF-110) targeting the following condition: To provide localized and extended post-operative analgesia..
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:PRFX last updated on 6/25/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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