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Drug Development/Clinical Research
BPH: The company successfully completed a Phase 3 clinical trial for the treatment of the symptoms of BPH. A single treatment with PRX302 (Topsalysin) demonstrated a statistically significant improvement in BPH symptoms over a 12-month period. The drug is designed to be as efficacious as pharmaceuticals, less invasive than surgical intervention, and without the sexual side effects seen with existing treatments.
The company already has a license agreement with Japan for commercialization of Topsalysin.
BPH is a $5 billion market with more than four million patients treated each year in the U.S. alone. The potential market for prostate cancer exceeds $1 billion.
The company is just one trial away from submitting an FDA application and can request the FDA to fast-track their application.