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# FDA Refuses to File Nymox Pharma NDA
- URL: https://www.fdaweb.com/fda-refuses-to-file-nymox-pharma-nda/
- Published: 2022-05-24T12:00:00.000Z
- Updated: 2026-09-14T17:46:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151883

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.