Overview
With over 30 million surgical procedures performed in the U.S. alone, there is a significant unmet need for new therapies for the management of post-surgical pain.
Current pain treatment options, specifically in the acute, post-surgical setting, have limited efficacy and carry with them significant side effects leading to serious health risks.
PRF-108 uses a proprietary Phospholipid Gel technology to provide a sub-dermal depot for Ropivacaine. This is the industry's first ropivacaine sustained released formulation that provides a local block anesthetic for post-operative pain.
The projected product profile is to deliver the gel through a sterile, prefilled syringe proximate to the surgical wound. It is anticipated that the pain relief will be sustained for a period of 3-4 days and be sufficient to reduce or eliminate the need for systemic analgesics or patient controlled analgesia. PRF-108 is designed to replace or augment existing post-surgical pain products.
Safety Profile
PRF-108 has been shown in pre-clinical studies to have a superior safety profile over the injectable solution. The formulation utilizes no new chemical entities and employs naturally occurring phospholipids and excipients that are generally regarded as safe (GRAS).
Benefits
Improves mobility to accelerate recovery and hasten hospital discharge
Eliminates the need for continuous infusion devices
Facilitates convenient administration with one-time dosage in a sterile, prefilled syringe
Enables effective pain treatment for a wide range of surgical procedures
Minimizes or eliminates the need for narcotic analgesics
Development Status
Proof of concept data in pre-clinical models has shown that PRF-108 may have some advantages over long-acting local anesthetic delivery formulations being developed by others.
Plans are underway to initiate clinical trials. NDA submission is targeted for as early as the first quarter of 2011, with commercialization to commence in 2012.
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