First Approval For Upjohn's Freedox

Upjohn has received approval to market Freedox IV (tirilazad mesylate injection) in Austria for the treatment of aneurysmal subarachnoid hemorrhage in male patients. This is the first regulatory approval for the lazaroid drug, notes the company.

Freedox is thought to achieve its neuroprotective properties via a number of different mechanisms, including inhibition of free radical generation, lipid peroxidation, stabilization of cell membranes and preservation of levels of endogenous antioxidants. Austria's regulation authority approved Freedox to enhance survival and improve functional recovery in male patients following SAH based on the results of a European/Australasian trial which showed a significant reduction in mortality in men.

Results of the study, conducted by neurosurgical centers in Australia, western Europe and New Zealand, revealed that a group of patients who received tirilazad mesylate at a dose of 6mg/kg a day had a 43% decrease in mortality compared to a placebo-treated group. The drug also reduced the need for expensive hypertensive rescue therapy by 44% in these patients, said the company. Small increases in injection-site phlebitis were the most commonly observed drug reaction.