We are a clinical stage specialty pharmaceutical company
focused on the reformulation of established therapeutics
Our 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 using opiates very often administered post-surgically.
Our strategy is to incorporate generic drugs which have been proven safe and effective with our proprietary extended drug-delivery system in order to create a significant improvement in therapy via extended-release drug products and to take advantage of the 505(b)(2) regulatory pathway created by the U.S. Food and Drug Administration (“FDA”). The 505(b)(2) new drug application (“NDA”) process provides for FDA approval of a new drug based in part on data that was developed by others, including published literature references and data previously reviewed by the FDA in its approval of a separate application. Using this pathway can significantly reduce the future time and costs associated with clinical development.
PRF-110, our first product, is based on the local anesthetic ropivacaine, targeting the post-operative pain relief market. PRF-110 is an oil-based, viscous, waterless and clear solution that is deposited directly into the surgical wound bed before closure to provide localized and extended post-operative analgesia.
We have initiated our phase III clinical trial for PRF–100. in the first part of its two-part Phase 3 clinical trial of PRF-110, which enrolled 15 bunionectomy patients at two clinical sites in Texas. PRF-110 was administrated intra-operatively to further validate the lead formulation’s safety and confirm optimal product instillation in the surgical wound. The initial results demonstrated a solid safety profile of PRF-110, with no serious adverse events (SAEs) reported.
Also, during Part I of this study, blood samples were collected at specified time points post-surgery, through 72 hours, to determine maximum plasma ropivacaine concentrations (Cmax). Cmax value among all 15 patients was approximately 10% of the safety window set by the FDA.
The surgeons participating in the PRF-110 Phase 2 trial reported that it was easily integrated into the procedure and non-disruptive of existing surgical techniques.
Ropivacaine, the active drug used in PRF-110, is a safe and well-characterized local anesthetic, and the other components that make up the remainder of the PRF-110 formulation are classified as GRAS (Generally Regarded As Safe) by the FDA, mitigating many potential safety issues that are common in drug development.