Savient Pharmaceuticals, Inc, has been conducting a clinical trial of its experimental gout treatment drug Puricase. Puricase is intended for use in patients that have not had success in treatment of their gout with other therapies.
The trial included 212 patients, of which 158 completed the randomized trial. The company reported that 19 of the patients that received Puricase during the trial experienced serious to severe infusion reactions, including chest and back pain.
Of the 212 patients, 3 that were receiving Puricase died during the trial, 1 in the placebo group died before the first placebo dose.
Today, Savient disclosed information about 2 deaths that occurred after completion of the study. One of these patients was assigned to the Puricase group and the other to the placebo group. That person’s death occurred 4 months after the last placebo was administered. According to Savient, the deaths were unrelated to Puricase.
Savient indicated that it does not request follow-up post-study information on patients that quit the trial or did not enroll in the Open Label Extension.
loading...
Originally posted 2008-02-29 18:37:39. Republished by Blog Post Promoter
Ther are currently no related posts.
