UPJOHN FILES US NDA FOR FREEDOX

The Upjohn Company has filed for approval of its lazaroid compound Freedox (tirilazad mesylate) for the treatment of severe aneurysmal subarachnoid hemorrhage in the USA. If approved, it will become the first available drug specifically licensed for this indication in this country, and is the first lazaroid compound to reach this stage of development.

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. The New Drug Application is based on trials carried out in the USA, Canada, the UK and Australia, and Upjohn is in the process of filing worldwide. Dossiers have been submitted so far in Austria, Belgium, Denmark, Finland, Iceland, Ireland, Italy, Mexico, the Netherlands, New Zealand, Norway, Spain, Sweden, Switzerland and the UK.

Freedox is being investigated for efficacy in Phase III clinical trials for three other indications, namely head injury, ischemic stroke and spinal cord injury. For head injury, two major studies are ongoing, one in North America (started December 1991) and one in Europe and Australia (started September 1992). There are also two studies ongoing for ischemic stroke, both of which started in mid-1993. All these studies are scheduled for completion during 1995, and will involve around 1,000 patients. A spinal cord injury trial is ongoing at the US National Institutes of Health, and will involve 495 patients.