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If approved by the Food and Drug Administration for this indication, prasterone would be appropriate as a first-line treatment for patients with mild to moderate disease, experts said.
Overall, 58% of women treated with prasterone experienced improvement or stabilization of their SLE, based on four disease-score instruments, compared with 46% of those in the placebo group, a statistically significant difference, reported Dr.
Among the 265 women in the study with active SLE at the time of entry, 66% improved or stabilized on prasterone vs.
The major adverse effects associated with prasterone were acne (35% of patients) and hirsutism (20% of patients).
When the analysis of this study is complete we plan to meet with the FDA and determine our course of action for Prestara(TM), our formulation of prasterone.
Separately, there is also a clinical trial of prasterone being conducted by Genovate Biotechnology Co.
The active ingredient in Prestara(TM) is prasterone, the synthetic equivalent of the androgenic hormone dehydroepiandrosterone (DHEA).
Professor of Medicine, Johns Hopkins University School of Medicine, is the lead author of the paper which is entitled "Effects of Prasterone on Disease Activity and Symptoms in Women with Active Systemic Lupus Erythematosus: Results of a Multicenter Randomized, Double-Blind, Placebo-Controlled Trial.