Upjohn's Lazaroid Drug Runs Into Trouble

In a major setback for the firm, Upjohn of the USA has announced that a pivotal trial of its lazaroid product Freedox (tirilazad mesylate) has had to be suspended after excess mortality was observed in the patient group receiving the drug. Freedox is being tested in the North American, 1,200-patient study as a treatment for severe and moderate head injury.

The suspension of the trial is a serious blow to the company, which is in the midst of a period of patent losses for several of its older products, including its Xanax (alprazolam) and Halcion (triazolam) brands. Freedox has been widely touted as the flagship new product which could drive Upjohn's earnings and help to offset this drain on revenues.

The company said it was disappointed and surprised by the finding of excess mortality, particularly as a similar pivotal trial carried out in Europe failed to uncover the same phenomenon. The dosing regimens used in the two trials were the same (10mg/kg for five days), and the populations of patients enrolled were comparable. The majority of deaths in the trial came about as a result of cerebral edema, which is part of the usual course of the lesions in these patients. The patients in the two trials will continue to be followed up for a further six months to see if there is any benefit from the drug and to determine why differing results were obtained.