Cerimon Initiates Clinical Study Of Topical Diclofenac Sodium Patch
Diclofenac Sodium Patch
Cerimon Pharmaceuticals has initiated a Phase I clinical study of a novel diclofenac sodium patch, the Company's lead pain asset. The study will evaluate safety, tolerability, and systemic pharmacokinetics of a topical patch formulation of diclofenac sodium, a non-steroidal anti-inflammatorydrug (NSAID), in 16 healthy volunteers. The Phase I study is expected to be completed in the fourth quarter of 2007. Following the completion of this study, Cerimon plans to rapidly initiate late-stage efficacy and safety studies of its diclofenac sodium patch in patients with acute musculoskeletal pain.
"Topical diclofenac is the second therapeutic product Cerimon has advanced into clinical studies this year, following the initiation of Phase IIb testing for Simulect (basiliximab) in the first quarter," stated Paul Sekhri, President and CEO of Cerimon Pharmaceuticals. "We are proud of this progress and believe the diclofenac patch will address the market need for safe and effective topical pain therapies. Currently, topical NSAIDs are marketed in Europe, Japan, and other parts of the world, but not in the U.S. Their advantage in treating musculoskeletal pain is the ability to deliver drug directly to the affected area with minimal systemic exposure.Given the systemic side effects of traditional non-topical NSAIDs, as well as the withdrawal of some COX-2 inhibitors, we believe developing a new treatment option is an important goal for the medical community."
Musculoskeletal pain is pain that affects the muscles, ligaments, and tendons. Acute musculoskeletal injuries are common and can occur during sports activities, exercise, or other physical activities. They often result in pain due to soft tissue injuries, such as sprains, strains, and minor contusions. While usually not serious, these injuries are often painful and result in temporary disability. Acute musculoskeletal injuries generally require rapid treatment. Primary treatment with cold compresses is often supported by administration of anti-inflammatory drugs. Optimal topical treatment should relieve acute pain and reduce swelling in the injured area to restore normal movement. In addition, it should be safe and easy to administer.
Pain represents a large and dynamic market in the U.S. Oral formulations of NSAIDs currently are marketed worldwide for the treatment of inflammation and pain, including pain due to musculoskeletal injuries, signs and symptoms of osteoarthritis and rheumatoid arthritis, menstrual cramps, headache and other minor aches and pains. While traditional oral NSAIDs are effective, they can cause serious gastrointestinal and other adverse events. Further, the withdrawal of some COX-2 inhibitors has removed a major therapeutic option for patients with multiple moderate and severe forms of pain, resulting in a significant market opportunity. These developments have created a significant need for a localized pain product with a strong safety profile.