The FDA has announced the approval of Noctiva desmopressin acetate nasal spray for the treatment of nocturnal polyuria (overproduction of urine at night). Allergan licensed SER120 desmopressin nasal spray from Serenity Pharmaceuticals in 2010.
In 2007, the FDA announced that intranasal desmopressin was no longer indicated for the treatment of nocturnal enuresis (bedwetting) due to the risk of hyponatremia. Last year, the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) voted 14-4 on the question of whether the benefits of SER120 desmopressin nasal spray for the treatment of nocturia outweigh the risks. The product is now approved for adults and will have a boxed warning regarding the risk of hyponatremia.
FDA’s Director of the Division of Bone, Reproductive, and Urologic Products Hylton V. Joffe said, “Today’s approval provides adults who overproduce urine at night with the first FDA-approved therapeutic option to help reduce the number of times a night they wake up to urinate. It is important to know that Noctiva is not approved for all causes of night-time urination, so patients should discuss their symptoms with their health care provider who can determine the underlying cause of the night-time urination and whether Noctiva is right for them.”
Read the FDA press release.
