Serenity Pharmaceuticals petitioned the FDA to deny approval of Ferring’s new drug application for a nocturia treatment, claiming the company did not demonstrate the drug’s safety or clinical benefit and did not design the drug to allow for a true safety assessment.

The company compared the product profiles of its own Noctiva (desmopressin acetate) and the new drug application, both designed to treat nocturia, a condition involving excessive nighttime urination. It claimed that there are important differences relating to dose, routes of administration, pharmacokinetic variability and excess desmopressin that make favor Noctiva a safer product.

It also pointed out differences in study methods between the two products that it claimed significantly impact Ferring’s approvability.