FDA committee votes to not recommend Ferring's desmopressin

15 January 2015

The US Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted not to recommend for approval the orally disintegrating tablet formulation of desmopressin from privately-held Switzerland-headquartered Ferring Pharmaceuticals.

Desmopressin was developed as an investigational treatment of nocturia due to nocturnal polyuria in adults who awaken two or more times each night to urinate.

The EMDAC voted 10 to five, with two abstentions, to recommend that the FDA not approve the drug. While the FDA is not required to follow the EMDAC vote, the agency carefully considers the recommendations when making a decision. The FDA is anticipated to make a final marketing decision regarding the drug by first-quarter 2015.

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