FDA Refuses to File Nymox Pharma NDA

FDA has issued Nymox Pharmaceutical a Refusal to File letter for its NDA for fexapotide triflutate for treating benign prostatic hyperplasia (BPH). The letter referenced a “new outstanding issue of longer-term safety data” and it indicated the submission needed to have longer-term safety data, Nymox says. “Longer-term full safety data (as long as six years after a single low dose non-systemic injection given one time only) was not requested by the FDA in any previous pre-NDA communications,” it says.

The company says that fexapotide’s safety profile is superior to any other conventional BPH treatment. “The FDA agreed at the end of Phase 2 that for eventual approval one-year safety data after a single injection of fexapotide 2.5 mg was adequate for Phase 3 pivotal studies and for clinical safety duration requirements,” it says, adding that there is no evidence of any long-term adverse safety outcomes in the drug’s pivotal study data.