SCHERING's EULEXIN WAS SCHEDULED TO REACH PHARMACIES BY FEB. 3
Executive Summary
SCHERING's EULEXIN WAS SCHEDULED TO REACH PHARMACIES BY FEB. 3, following FDA marketing approval on Jan. 27 for concomitant treatment of advanced metastatic prostatic cancer. The company said it is currently making automatic shipments of Eulexin (Flutamide) to wholesalers by air. The oral androgen product is supplied in 125 mg capsules in bottles of 100 and 500, as well as in unit-dose packages of 100. "Eulexin capsules are indicated for use in combination with LHRH agonistic analogs (such as leuprolide acetate) for the treatment of metastatic prostatic carcinoma," approved FDA labeling states. "To achieve the benefit of the adjunctive therapy with Eulexin, treatment must be started simultaneously with both drugs." The recommended dosage for Eulexin is two capsules three times daily. Conducted by the National Cancer Institute, the major U.S. trial of flutamide included over 600 patients at a number of centers. The study found that patients randomized to leuprolide (TAP's Lupron) plus flutamide survived a mean of seven months longer, or an increment of nearly 25%, than patients who received leuprolide plus placebo. Side effects occurring in patients on combined therapy included hot flashes, decrease in libido, impotence and gynecomastia. Incidence of diarrhea was higher with patients in the active group, 12% vs. 4%.