Genelabs submits Prestara protocol
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Genelabs submits protocol for Phase III trial of its lupus therapy Prestara, with intent of confirming prasterone's positive effect on bone mineral density. FDA requested the trial in Aug. 28 "approvable" letter (Pharmaceutical Approvals Monthly, September 2002, In Brief). Genelabs hopes to begin the 110-patient, six-month trial before the end of the year. The trial will use bone mineral density at the lumbar spine as primary endpoin