Pharmaceutical Business review

CapGenesis submits orphan drug designation requests in US and Europe for CGS-200

CGS-200 is a novel high-strength topical formulation of the TRPV1 channel agonist trans-capsaicin combined with hyaluronic acid.

It has been designed to deliver long-term desensitization of nerve fibers that carry out sensation at the targeted site of pain.

Acute osteomyelitis is a severe bone inflammation that can result from an earlier trauma. It can occur after surgical reduction of bone breaks or joint replacements.

Osteosarcoma is a rare form of primary bone cancer, while Osteonecrosis, also known as avascular necrosis, occurs due to temporary or permanent loss of the blood supply to the bones.

Paget’s disease is a common bone disorder, while Morton’s neuroma is a painful condition that affects the ball of the foot which is the area between the third and fourth toes.

CapGenesis chief medical officer Stanley Pillemer said: "We believe previously collected clinical data on the effectiveness of one of our other trans-capsaicin formulations in osteoarthritis suggests that the higher concentrations of capsaicin delivered with CGS-200 has the potential for therapeutic benefits that may add to existing treatments for the pain associated with these debilitating conditions, without deleterious systemic side effects or risks.

"Our goal is to pursue clinical evidence supporting the approval of CGS-200 in these orphan indications in both the U.S. and European markets."