FDA Advisory Committee recommends SER 120 ( low-dose nasal formulation of desmopressin) for patients with nocturnal polyuria. - Allergan

The Bone, Reproductive and Urologic Drugs Advisory Committee of the FDA has voted 14-4 in favour of approving SER 120, a low-dose nasal formulation of desmopressin , from Allergan, as a therapy for nocturia, the need to wake and pass urine at night on more than two occasions.

The panel has reportedly recommended that the FDA restrict the use of SER 120 to a subset of patients who have nocturnal polyuria - when there is an increase in nighttime urine production with a corresponding drop in daytime production, resulting in a normal 24-hour urine volume. In briefing papers posted to the FDA's website ahead of the meeting, it was noted that post hoc analyses suggest that patients with nocturnal polyuria might have a slightly greater response to SER 120 than patients without.