MEMPHIS, Tennessee—Toremifene citrate (Acapodene) 80 mg reduced the occurrence of vertebral fractures and met other key endpoints in a phase III trial of 1,389 men receiving androgen deprivation therapy for advanced prostate cancer, GTx, Inc. said in a press release. Based on these findings, the company plans to file a New Drug Application with FDA by the summer of this year for the treatment of multiple side effects of ADT.
In an intent-to-treat analysis of the 2-year double-blind randomized study data, the selective estrogen-receptor modulator (SERM) reduced the occurrence of new morphometric vertebral fractures by 53%, compared with placebo (P = .034). Patients on the study drug also had significant increases in bone mineral density, decreased total cholesterol and triglyceride levels, increased HDL cholesterol levels, and significant improvements in gynecomastia. Full results will be presented at an upcoming medical meeting, the company said.