FDA Events for PainReform (PRFX)
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:
- 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- Drug:
- PRF-110
- Announced Date:
- August 21, 2024
- Indication:
- To provide localized and extended post-operative analgesia.
Announcement
PainReform Ltd announced the successful determination of the optimal delivery method for PRF-110 in bunionectomy procedures.
AI Summary
PainReform Ltd. recently announced a major milestone in its clinical development of PRF-110. The company successfully determined the optimal delivery method for administering PRF-110 in bunionectomy procedures. This precise delivery technique uses a cannula connected to a syringe’s Luer lock, ensuring that the product covers nerve endings and traumatized tissue surfaces effectively, which is essential for controlling pain after surgery.
The Phase III evaluations showed that PRF-110 exhibits the ideal viscosity and uniformity to adhere well over the wound bed. This innovative approach overcomes challenges seen in other pain management solutions, such as difficulties in achieving complete wound coverage. As a result, PRF-110 is positioned to offer improved post-surgical pain relief through a single application, potentially reducing the need for repeated dosing or opiate use in bunionectomy procedures.
Read Announcement- Drug:
- PRF-110
- Announced Date:
- August 20, 2024
- Indication:
- To provide localized and extended post-operative analgesia.
Announcement
PainReform Ltd. announced encouraging early safety results from its ongoing Phase 3 bunionectomy study of PRF-110, the Company's proprietary post-surgical pain formulation.
AI Summary
PainReform Ltd. has shared promising early safety results from its ongoing Phase 3 study of PRF-110, a new post-surgical pain formulation aimed at patients undergoing bunionectomy. The study, which enrolled 443 patients at eight clinical sites in the United States, follows a randomized, double-blind, placebo-controlled design, ensuring robust data collection on the drug's performance.
Initial findings indicate a very favorable safety profile for PRF-110, with subjects experiencing an average of just one adverse event during the trial. The formulation is based on the established safety of ropivacaine combined with GRAS (Generally Recognized As Safe) components, suggesting that PRF-110 could become an effective non-opioid alternative for managing post-operative pain. These early safety results support the continued development of PRF-110 as a potential breakthrough in post-surgical pain management.
Read Announcement- Drug:
- PRF-110
- Announced Date:
- August 15, 2024
- Indication:
- To provide localized and extended post-operative analgesia.
Announcement
PainReform Ltd. provided a business update for the second quarter ended June 30, 2024.
AI Summary
PainReform Ltd. provided a business update for the second quarter ended June 30, 2024, highlighting major progress for its lead drug candidate, PRF-110. The company successfully completed the second part of its Phase 3 clinical trial in bunionectomy, enrolling 443 patients at eight U.S. clinical sites. Top-line results from this trial are expected to be announced later in 2024.
Additionally, PainReform introduced a new, highly scalable manufacturing process for PRF-110. This process achieved 18 months of full product stability at room temperature, a key breakthrough that could ease handling, improve transportation logistics, reduce associated costs, and enhance future commercialization efforts. The business update underscores the company’s commitment to advancing PRF-110 as a promising alternative for postoperative pain management while reducing the reliance on opioids.
Read Announcement- Drug:
- PRF-110
- Announced Date:
- August 7, 2024
- Indication:
- To provide localized and extended post-operative analgesia.
Announcement
PainReform Ltd. announced compelling safety data for its lead product candidate, PRF-110.
AI Summary
PainReform Ltd. has announced compelling safety data for its top product candidate, PRF-110. This data was collected from pharmacokinetic studies during herniorrhaphy and bunionectomy clinical trials. The studies showed that the maximum blood level of PRF-110 reached only about 10% of the FDA safety threshold, which is very promising for patient safety.
PRF-110 is formulated with ropivacaine—a well-regarded local anesthetic known for its safe profile—and is designed to be applied directly to the surgical wound. Its oil-based, viscous formulation allows for a controlled release of the active ingredient, which can help provide long-lasting pain relief while reducing the risk of system toxicity.
These results suggest that PRF-110 may play a significant role in managing postoperative pain safely across a range of surgical procedures.
Read Announcement- Drug:
- PRF-110
- Announced Date:
- July 24, 2024
- Indication:
- To provide localized and extended post-operative analgesia.
Announcement
PainReform Ltd. announced it has filed a patent covering its new and highly scalable manufacturing process for PRF-110, its flagship product designed to revolutionize post-operative pain control.
AI Summary
PainReform Ltd. has reached a major milestone by filing a patent for its new, highly scalable manufacturing process for PRF-110, a product designed to change the way post-operative pain is managed. This patent, filed after successful testing of the process, protects the innovative techniques that promise smoother scale-up and efficient production.
The process incorporates continuous manufacturing using a single reactor, which not only simplifies the production procedure but also minimizes contamination risks and reduces equipment and maintenance costs. With the ability to produce larger batch sizes while keeping strict quality standards, this new method is expected to lower production expenses. PainReform’s commitment to innovation and quality could pave the way for a future market launch of PRF-110, offering a potentially safer, effective non-opioid option for post-surgical pain relief.
Read Announcement- Drug:
- PRF-110
- Announced Date:
- June 26, 2024
- Indication:
- To provide localized and extended post-operative analgesia.
Announcement
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. .
AI Summary
PainReform Ltd has reached a significant milestone by completing patient enrollment in its Phase 3 trial for PRF-110, a novel analgesic aimed at treating post-operative pain. The company enrolled a total of 428 patients at eight clinical sites across the U.S. in a randomized, double-blind, placebo-controlled study focusing on patients undergoing bunionectomy. The investigational drug uses an oil-based, extended-release formulation of the local anesthetic ropivacaine, designed to provide long-lasting pain relief while reducing the need for repeated opioid dosing. The trial’s primary objective is to demonstrate a significant reduction in post-operative pain intensity over the first 72 hours after surgery, with additional goals to assess overall safety, tolerability, and the use of rescue analgesics. Top-line results are expected in the second half of 2024, potentially paving the way for regulatory submission and future commercialization.
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 December 27, 2024, involving PRF-110. The update was categorized as "Provided Update," with the company reporting: "PainReform Ltd. nnounced an update regarding its Phase 3 clinical trial evaluating PRF-110 in post-surgical pain management of patients undergoing bunionectomy."
Currently, PainReform has one therapy (PRF-110) targeting the following condition: To provide localized and extended post-operative analgesia..
More FDA Event Resources from MarketBeat
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
This page (NASDAQ:PRFX) was last updated on 7/10/2025 by MarketBeat.com Staff
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