PainReform Provides Regulatory Update on Second Part of its Phase 3 Clinical Trial of PRF-110 in Patients Undergoing Bunionectomy Surgery
TEL AVIV, Israel, June 07, 2023 (GLOBE NEWSWIRE) -- (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today provided a regulatory update on the second part of its Phase 3 clinical trial of PRF-110 in patients undergoing bunionectomy surgery. The Company’s supplier of the API (active pharmaceutical ingredient) has received a deficiency notice from the FDA related to its Drug Master File (DMF). The DMF is the file on record with the FDA representing the manufacturing process and facility for the production of the API. As a result, the second part of the Phase 3 trial is expected to commence once the required information has been provided by the supplier to the FDA and the deficiency notice has been resolved. None of the issues raised relate to the Company’s PRF-110 product.
Ilan Hadar, Chief Executive Officer of PainReform, stated, “Although we encountered what will likely be a delay in starting the second part of the Phase 3 trial, we are working closely with our API supplier to ensure the matter is resolved in the most expedient manner possible. These circumstances were out of our control, but we believe our supplier is taking the necessary steps, which should enable us to commence the second part of the trial in as short a timeframe as possible. We look forward to providing near-term updates about the timeline as soon as practicable.”
“We do not believe that the deficiency noted has or would have any risk to patients. Moreover, it is important to note that Ropivacaine, the active drug used in PRF-110, has been shown to be a safe, well-tolerated, and well-characterized local anesthetic for many years. We are therefore confident of the safety and quality of our product and the outlook for this program. We believe PRF-110 holds tremendous promise and will ultimately contribute to a reduction in the frequency of opiate use following surgical procedures, thereby lessening the risk of opiate abuse disorder and ultimately saving lives.”
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
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Crescendo Communications, LLC
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Ilan Hadar
Chief Executive Officer
PainReform Ltd.
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