Methylprednisolone suleptanate Pharmacia Corp.

Methylprednisolone suleptanate (Promedrol) is a prodrug of methylprednisolone being developed by Pharmacia Corp (formerly Pharmacia & Upjohn) for the treatment of asthma. It has been approved for this indication in Switzerland and is awaiting registration in several other countries [211246]. Preliminary preclinical data indicated the potential use of methylprednisolone suleptanate for the i.v. treatment of immunological disease. Its anti-inflammatory/bronchodilatory effect was demonstrated in mice and rats and in a guinea pig model [271975]. Animal models have also demonstrated the use of methylprednisolone suleptanate for the treatment of nephritis and hypotension. Efficacy and safety of pulse therapy Promedrol was demonstrated in a phase II trial using lupus nephritis patients. The recommended dose for pulse therapy is 400 mg equivalent/day i.v. [271975]. Other studies in lupus patients have shown that doses of up to 1000 mg/day are well tolerated [307789] and pulse therapy with either 400 or 800 mg/day are efficacious in delaying the onset of CNS symptoms in SLE patients with organic brain disease [307512]. Preclinical studies are also taking place for the potential treatment of spinal cord injury [344254]. In April 2000, Morgan Stanley Dean Witter estimated sales would be US $281 million in 2003, rising to $277 million in 2004 [375906].