Genelabs Technologies, Inc. reported recently that in a 9-month, Phase III trial, treatment with Prestara (prasterone), a synthetic form of the human hormone dehydroepiandrosterone, failed to achieve the primary endpoint of improving bone mineral density (BMD) in the lumbar spine in women with systemic lupus erythematosus receiving concomitant glucocorticoids.

In August 2002 the US Food and Drug Administration issued an approvable letter for Genelabs' Prestara new drug application. Approval of Prestara was contingent primarily on the successful completion of an additional clinical trial that provided sufficient evidence to confirm the positive effect on BMD in women with mild to moderate lupus taking glucocorticoids, which had been observed in an earlier Phase III study.

The current results are the second attempt to verify these results. In August 2004, Genelabs completed an additional 6-month Phase III trial which also failed to detect a positive effect of Prestara on BMD.