Nymox Plans to Submit NDA for Novel Benign Prostatic Hyperplasia Treatment
Nymox Pharmaceutical Corporation has announced they plan to submit a New Drug Application (NDA) for fexapotide triflutate, an investigational treatment for benign prostatic hyperplasia (BPH).
The safety and efficacy of fexapotide triflutate (FT) 2.5mg transrectal injectable was assessed in two Phase 3 placebo-controlled trials involving 995 BPH patients. Results showed that at long-term follow-up (mean 3.58 years), the Symptom Score change from baseline (primary endpoint) was -5.2 vs. -3.0 for the FT-treated group and placebo group, respectively (P<0.0001). The incidence of acute urinary retention (1.08% P=0.0058) and prostate cancer (1.1% P=0.0116) were both reduced in the FT-treated group.
No significant safety differences were noted for FT injection versus placebo.
The Company stated that they will officially submit the NDA later this year.
For more information visit Nymox.com.