Acute rejection remains the most important clinial problem facing transplant patients, and is still the most frequent cause of allograft failure. In addition, treatment of an acute rejection episode with even higher doses of immunosupressive drugs can lead to over-immunosuppression and life-threatening complications. Since gaining FDA approval in 1983, cyclosporine has improved renal allograft survival rates by reducing the incidence of acute rejection episodes. Sandoz Pharmaceuticals discovered and introduced cyclosporine into clinical practice as the liquid formulation, Sandimmune. In 1995, Sandoz introduced a new microemulsion formulation, Neoral, with substantially enhanced pharmacokinetic characteristics. Cyclosporine, the most potent and specific immunosupressant ever developed, revolutionized renal transplantation. Unfortunately, the cost of this drug, for most patients, is in excess of $5,000 per year. In 1996, its patent expired, opening the door for generic equivalents. The purpose of this study is to demonstrate, in renal transplant recipients, that a new generic cyclosporine formulation, SANG-35, is equal in terms of safety, tolerability, and pharmacokinetic profile with the FDA-approved and currently marketed Neoral. The anticipation of the sponsoring company is that such a compound, if acceptable to the transplant community, could be marketed at a substantial discount to currently available cyclosporine formulations.
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