FDA Approves Noctiva for Nocturnal Polyuria, Following Ad Comm Recommendations
FDA approved Noctiva, a nasal spray for the treatment of nocturnal polyuria, or waking up to urinate at least twice per night. The Serenity Pharmaceuticals product is the first FDA-approved treatment for the condition, but it is not approved for all causes of night-time urination.
Serenity initially pursued an approval of Noctiva (desmopressin acetate) to treat the broader symptom of nocturia, or waking at night to urinate, which can be caused by a variety of conditions. The majority of members of an FDA advisory committee recommended that the drug instead be approved for a clinical diagnosis of nocturnal polyuria. The product is being approved with a boxed warning and a Medication Guide, because it can cause low sodium levels in the blood.
Noctiva’s efficacy was evaluated in two 12-week trials of 1,045 patients. Compared to placebo, more patients treated with Noctiva were able to at least halve their number of night-time urinations.