Avadel Petitions FDA to Shoot Down Ferring’s Nocturia Treatment

May 22, 2018

Avadel Specialty Pharmaceuticals called on the FDA to deny approval for certain demopressin acetate treatments for nocturia, including a pending drug application by Ferring, expressing concern over the pharmaceutical company’s clinical trial data and patent certification for the drug.

Avadel, whose product Noctiva is the only FDA-approved treatment for nocturia due to nocturnal polyuria, suggested that the agency withhold approval of Ferring’s desmopressin new drug application and other NDAs unless they are supported by clinical trials that include Phase 3 study data, as well as a minimum of two clinical studies for both genders if gender-specific dosing regimens are required.

The Noctiva manufacturer also criticized the subject population in Ferring’s clinical trial, stating that clinical trial enrollment for Noctiva NDAs should be restricted to patients aged 50 or older.

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